No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00190446735922 | 342-13-705 | EMPOWR 3D KNEETM INS, 5R 13MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
2 | 00190446735915 | 341-13-705 | EMPOWR 3D KNEETM INS, 5L 13MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
3 | 00190446735762 | 341-11-702 | EMPOWR 3D KNEETM INS, 2L 11MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
4 | 00190446302636 | 414922 | 2.0 AND 2.7MM SCREW DRIVER HANDLE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | DJO SURGICAL | |
5 | 00190446747482 | 800-05-096 | DJO EMPOWR REVISION KNEE, FEMORAL TRIAL LOCATOR, SZ 6-11 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
6 | 00190446747468 | 800-05-095 | DJO EMPOWR REVISION KNEE, FEMORAL TRIAL LOCATOR, SZ 2-5 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
7 | 00190446745266 | 800-05-094 | DJO EMPOWR REVISION KNEE, FEMORAL FLEXION TOWER 0/3 | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
8 | 00190446302605 | 414916 | DISCOVERY XS HUM RES TEMPLATE | HWT | TEMPLATE | 1 | DJO SURGICAL | |
9 | 00190446736165 | 342-13-711 | EMPOWR 3D KNEETM INS, 11R 13MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
10 | 00190446302582 | 414913 | DISCOVERY XS FOSSA REAMER | HTO | REAMER | 1 | DJO SURGICAL | |
11 | 00190446736158 | 341-13-711 | EMPOWR 3D KNEETM INS, 11L 13MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
12 | 00190446302575 | 414912 | DISCOVERY 5 STEP FOSSA REAMER | HTO | REAMER | 1 | DJO SURGICAL | |
13 | 00190446736141 | 342-11-711 | EMPOWR 3D KNEETM INS, 11R 11MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
14 | 00190446736134 | 341-11-711 | EMPOWR 3D KNEETM INS, 11L 11MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
15 | 00190446736127 | 342-13-710 | EMPOWR 3D KNEETM INS, 10R 13MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
16 | 00190446736110 | 341-13-710 | EMPOWR 3D KNEETM INS, 10L 13MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
17 | 00190446302292 | 414868 | DISC 2.5MM RIGHT ULNA RASP | HTQ | BROACH | 1 | DJO SURGICAL | |
18 | 00190446736103 | 342-11-710 | EMPOWR 3D KNEETM INS, 10R 11MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
19 | 00190446302285 | 414867 | DISC 2.5MM LEFT ULNA RASP | HTQ | BROACH | 1 | DJO SURGICAL | |
20 | 00190446736097 | 341-11-710 | EMPOWR 3D KNEETM INS, 10L 11MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
21 | 00190446736080 | 342-13-709 | EMPOWR 3D KNEETM INS, 9R 13MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
22 | 00190446736073 | 341-13-709 | EMPOWR 3D KNEETM INS, 9L 13MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
23 | 00190446736066 | 342-11-709 | EMPOWR 3D KNEETM INS, 9R 11MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
24 | 00190446736059 | 341-11-709 | EMPOWR 3D KNEETM INS, 9L 11MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
25 | 00190446736042 | 342-13-708 | EMPOWR 3D KNEETM INS, 8R 13MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
26 | 00190446736035 | 341-13-708 | EMPOWR 3D KNEETM INS, 8L 13MM, VE | JWH,OIY | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER,Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive | 2 | DJO SURGICAL | |
27 | 00190446736028 | 342-11-708 | EMPOWR 3D KNEETM INS, 8R 11MM, VE | OIY,JWH | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + add Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive,PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
28 | 00190446764335 | 803-03-241 | MODULAR T-HANDLE, LINEAR PLUS | LXH | Orthopedic manual surgical instrument | 1 | DJO SURGICAL | |
29 | 00190446764274 | 800-99-161 | EMPOWR REVISION KNEE, HALF-TRAY LID | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | DJO SURGICAL | |
30 | 00190446757672 | 800-99-160 | EMPOWR REVISION KNEE, OUTLIER TRAY, SZ: 2-3, 10-11 | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | DJO SURGICAL | |
31 | 00190446301950 | 414820 | DISC 3.5MM DIST HUMERAL RASP | HTQ | BROACH | 1 | DJO SURGICAL | |
32 | 00190446757665 | 800-99-159 | EMPOWR REVISION KNEE, CORE TRAY, SZ: 4-9 | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | DJO SURGICAL | |
33 | 00190446301912 | 414815 | DISC 3.5X124MM PROX HUM RASP | HTQ | BROACH | 1 | DJO SURGICAL | |
34 | 00190446754282 | 800-05-098 | DJO EMPOWR REVISION KNEE, STEM EXTENDER TRIAL, 15MM X 25MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
35 | 00190446753957 | 800-05-097 | DJO EMPOWR REVISION KNEE, ANTERIOR CUT GUIDE, SIZE 6-11 | FZX | Guide, surgical, instrument | 1 | DJO SURGICAL | |
36 | 00190446750734 | 800-05-093 | DJO EMPOWR REVISION KNEE, 3.5MM BALL END HEX DRIVER | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
37 | 00190446735663 | 800-05-122 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 10/11, 10MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
38 | 00190446735656 | 800-05-121 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 8/9, 10MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
39 | 00190446735649 | 800-05-120 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 6/7, 10MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
40 | 00190446301905 | 414814 | DISC 3.5X84MM PROX HUM RASP | HTQ | BROACH | 1 | DJO SURGICAL | |
41 | 00190446735632 | 800-05-119 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 4/5, 10MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
42 | 00190446735625 | 800-05-118 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 2/3, 10MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
43 | 00190446735618 | 800-05-117 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 10/11, 5MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
44 | 00190446735601 | 800-05-116 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 8/9, 5MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
45 | 00190446296652 | 803-42-44K | Trial Liner, EMPOWR Acetabular, 10°, 44K | FZX | Guide, surgical, instrument | 1 | DJO SURGICAL | |
46 | 00190446735595 | 800-05-115 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 6/7, 5MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
47 | 00190446735588 | 800-05-114 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 4/5, 5MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
48 | 00190446735571 | 800-05-113 | DJO EMPOWR REVISION KNEE, DISTAL AUG TRIALS, SZ 2/3, 5MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
49 | 00190446735564 | 800-05-112 | DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 10/11, 10MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL | |
50 | 00190446735557 | 800-05-111 | DJO EMPOWR REVISION KNEE, POST AUG TRIALS, SZ 8/9, 10MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | DJO SURGICAL |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00822409043231 | SST2081 | TIBIAL SPACER MOLD LARGE | SURESPACE | ORTHO DEVELOPMENT CORPORATION | |
2 | 00822409043224 | SST2070 | TIBIAL SPACER MOLD MEDIUM | SURESPACE | ORTHO DEVELOPMENT CORPORATION | |
3 | 00822409043217 | SST2058 | TIBIAL SPACER MOLD SMALL | SURESPACE | ORTHO DEVELOPMENT CORPORATION | |
4 | 00822409043200 | SSF1075 | FEMORAL SPACER MOLD LARGE | SURESPACE | ORTHO DEVELOPMENT CORPORATION | |
5 | 00822409043194 | SSF1067 | FEMORAL SPACER MOLD MEDIUM | SURESPACE | ORTHO DEVELOPMENT CORPORATION | |
6 | 00822409043187 | SSF1060 | FEMORAL SPACER MOLD SMALL | SURESPACE | ORTHO DEVELOPMENT CORPORATION | |
7 | 00822409007608 | 669-2081 | Large 52A/P x 81M/L Tibial Spacer Mold | KASM | ORTHO DEVELOPMENT CORPORATION | |
8 | 00822409007592 | 669-2070 | Medium 45A/P x 70M/L Tibial Spacer Mold | KASM | ORTHO DEVELOPMENT CORPORATION | |
9 | 00822409007585 | 669-2058 | Small 39A/P x 58M/L Tibial Spacer Mold | KASM | ORTHO DEVELOPMENT CORPORATION | |
10 | 00822409007578 | 669-1075 | Large 53A/P x 75M/L Femoral Spacer Mold | KASM | ORTHO DEVELOPMENT CORPORATION | |
11 | 00822409007561 | 669-1067 | Medium 44A/P x 67M/L Femoral Spacer Mold | KASM | ORTHO DEVELOPMENT CORPORATION | |
12 | 00822409007554 | 669-1060 | Small 37A/P x 60M/L Femoral Spacer Mold | KASM | ORTHO DEVELOPMENT CORPORATION | |
13 | 00815212024450 | KIVA2200E | KIT: VCF Treatment, LEFT, FRACTURE | IZI MEDICAL PRODUCTS, LLC | ||
14 | 00815212024443 | KIVA2100E | KIT: VCF Treatment, RIGHT, FRACTURE | IZI MEDICAL PRODUCTS, LLC | ||
15 | 00815212023606 | ACC5270 | KIVA INTRODUCER SET | IZI MEDICAL PRODUCTS, LLC | ||
16 | 00815212023590 | ACC5350 | KIVA ULTRAFLEX CEMENT NEEDLE KIT | IZI MEDICAL PRODUCTS, LLC | ||
17 | 00815212023514 | PLT2200 | PILOT:GEN A,LEFT | IZI MEDICAL PRODUCTS, LLC | ||
18 | 00815212023507 | PLT2100 | PILOT:GEN A,RIGHT | IZI MEDICAL PRODUCTS, LLC | ||
19 | 00815212023491 | KIV2200 | KIT:VCF TREATMENT,LEFT,FRACTURE | IZI MEDICAL PRODUCTS, LLC | ||
20 | 00815212023484 | KIV2100 | KIT:VCF TREATMENT,RIGHT,FRACTURE | IZI MEDICAL PRODUCTS, LLC | ||
21 | 00813478020056 | FRS2200 | FRS2200 | Kiva VCF Treatment System, First Fracture, Left | Kiva | BENVENUE MEDICAL, INC. |
22 | 00813478020049 | FRS2100 | FRS2100 | Kiva VCF Treatment System, First Fracture, Right | Kiva | BENVENUE MEDICAL, INC. |
23 | 00813478020032 | KIV2250 | KIV2250 | Kiva VCF Treatment System, Additional Fracture Kit, Left | Kiva | BENVENUE MEDICAL, INC. |
24 | 00813478020025 | KIV2200 | KIV2200 | Kiva VCF Treatment System, First Fracture Kit, Left | Kiva | BENVENUE MEDICAL, INC. |
25 | 00813478020018 | KIV2150 | KIV2150 | Kiva VCF Treatment System, Additional Fracture Kit, Right | Kiva | BENVENUE MEDICAL, INC. |
26 | 00813478020001 | KIV2100 | KIV2100 | Kiva VCF Treatment System, Fisrt Fracture Kit, Right | Kiva | BENVENUE MEDICAL, INC. |
27 | 00810012483117 | 95-7187 | BONE CEMENT CUP SPLITTER | BIOPRO, INC. | ||
28 | 00810012483100 | 95-7186 | BONE CEMENT ACETABULAR GOUGE, 20MM | BIOPRO, INC. | ||
29 | 00190446138013 | 600-15-100 | COBALT G-HV BONE CEMENT 40GM | DJO SURGICAL | ENCORE MEDICAL, L.P. | |
30 | 00190446138006 | 600-15-000 | COBALT HV BONE CEMENT 40GM | DJO SURGICAL | ENCORE MEDICAL, L.P. | |
31 | 00190446137993 | 600-10-100 | COBALT-G MV BONE CEMENT 40GM | DJO SURGICAL | ENCORE MEDICAL, L.P. | |
32 | 00190446137993 | 600-10-100 | COBALT-G MV BONE CEMENT 40GM | DJO SURGICAL | ENCORE MEDICAL, L.P. | |
33 | 00190446137986 | 600-10-000 | COBALT MV BONE CEMENT 40GM | DJO SURGICAL | ENCORE MEDICAL, L.P. | |
34 | B5780011191400115 | LV+G | 00-1119-140-01 | PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin.PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. | PALACOS | HERAEUS MEDICAL GMBH |
35 | B5780011191400115 | LV+G | 00-1119-140-01 | PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin.PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. | PALACOS | HERAEUS MEDICAL GMBH |
36 | B5780011181400114 | LV | 00-1118-140-01 | PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone c PALACOS® LV is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALACOS® LV contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field it has been coloured with chlorophyll (E141).The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. | PALACOS | HERAEUS MEDICAL GMBH |
37 | B578001113140011 | R+G | 00-1113-140-01 | PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone su PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation. | PALACOS | HERAEUS MEDICAL GMBH |
38 | B578001113140011 | R+G | 00-1113-140-01 | PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone su PALACOS® R+G is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, initially produces a liquid and then a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and Transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive serves as optical marking of the bone cement at the site of the operation. | PALACOS | HERAEUS MEDICAL GMBH |
39 | B578001112140011 | R | 00-1112-140-01 | PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone ce PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes. | PALACOS | HERAEUS MEDICAL GMBH |
40 | 28031497001399 | 13A2020 | Cemex System Fast 40g is a polymethylmethacrylate bone cement with a fast settin Cemex System Fast 40g is a polymethylmethacrylate bone cement with a fast setting. Cemex System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system.The device is supplied sterile, for single use.Cemex System Fast 40g is indicated for the fixation of joint prosthesis implants to the host bone. | CEMEX SYSTEM FAST 40G | TECRES SPA | |
41 | 28031497001382 | 13C2040 | Mendec Spine HV System is indicated for the treatment of pathological fractures Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure.Mendec Spine HV System is a closed sysyem which containes the powder and liquid components separately.The device is disposable and sterile. | Mendec Spine HV System | TECRES SPA | |
42 | 28031497000958 | 13A2111 US | Cemex Genta System Fast 40g is an antibiotic-loaded polymethylmethacrylate bone Cemex Genta System Fast 40g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system and has a fast setting. The device is supplied sterile, for single use.Cemex Genta System Fast 40g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | CEMEX GENTA SYSTEM FAST 40G | TECRES SPA | |
43 | 28031497000958 | 13A2111 US | Cemex Genta System Fast 40g is an antibiotic-loaded polymethylmethacrylate bone Cemex Genta System Fast 40g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System Fast 40g holds the powder (40g) and liquid (16,7g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system and has a fast setting. The device is supplied sterile, for single use.Cemex Genta System Fast 40g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared. | CEMEX GENTA SYSTEM FAST 40G | TECRES SPA | |
44 | 28031497000668 | SPC0522 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
45 | 28031497000651 | SPC0422 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
46 | 28031497000644 | SPC0322 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
47 | 28031497000637 | SPC0222 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
48 | 28031497000620 | SPC0122 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement coated onto a stainless steel reinforcing structure. The device is sterile and single-use. InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
49 | 28031497000613 | SPC0022 | Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed Temporary hip spacer with gentamicin. InterSpace Hip is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cementcoated onto a stainless steel reinforcing structure. The device is sterile and single-use.InterSpace Hip is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Hip is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Hip | TECRES SPA | |
50 | 28031497000606 | SPK0222 | Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully form Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement.The device is sterile and single-use.InterSpace Knee is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implantand radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). | InterSpace Knee | TECRES SPA |