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 | 08058964726087 | 900001 144818 | "Disposable cement spacer molds with metal reinforcement stem are indicated for "Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge." | SpaceFlex Shoulder | G21 SRL | |
2 | 08058964726070 | 900001 124818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
3 | 08058964726063 | 900001 124215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
4 | 08058964726056 | 900001 104818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
5 | 08058964726049 | 900001 104215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
6 | 08058964724977 | 900001 084215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
7 | 08033390216418 | 9013.67.146 | 9013.67.146 | PRIMA - Impactor Adaptor #6 | PRIMA | LIMACORPORATE SPA |
8 | 08033390230599 | 9CCS.10.001 | 9CCS.10.001 | ProMade shoulder 140° Reverse Resection Jig | SMR Shoulder | LIMACORPORATE SPA |
9 | 08033390226172 | 9CCS.13.003 | 9CCS.13.003 | Compactor S | SMR Shoulder | LIMACORPORATE SPA |
10 | 08033390226165 | 9CCS.13.002 | 9CCS.13.002 | Glenoid Drill Peg S | SMR Shoulder | LIMACORPORATE SPA |
11 | 08033390216821 | 9013.67.067 | 9013.67.067 | PRIMA - Metaphyseal Size ring #7 | PRIMA | LIMACORPORATE SPA |
12 | 08033390216814 | 9013.67.066 | 9013.67.066 | PRIMA - Metaphyseal Size ring #6 | PRIMA | LIMACORPORATE SPA |
13 | 08033390216807 | 9013.67.064 | 9013.67.064 | PRIMA - Metaphyseal Size ring #4 | PRIMA | LIMACORPORATE SPA |
14 | 08033390216791 | 9013.67.065 | 9013.67.065 | PRIMA - Metaphyseal Size ring #5 | PRIMA | LIMACORPORATE SPA |
15 | 08033390216784 | 9013.67.063 | 9013.67.063 | PRIMA - Metaphyseal Size ring #3 | PRIMA | LIMACORPORATE SPA |
16 | 08033390216777 | 9013.67.062 | 9013.67.062 | PRIMA - Metaphyseal Size ring #2 | PRIMA | LIMACORPORATE SPA |
17 | 08033390216760 | 9013.67.061 | 9013.67.061 | PRIMA - Metaphyseal Size ring #1 | PRIMA | LIMACORPORATE SPA |
18 | 08033390216609 | 9013.67.140 | 9013.67.140 | PRIMA - Impactor | PRIMA | LIMACORPORATE SPA |
19 | 08033390216470 | 9013.67.141 | 9013.67.141 | PRIMA - Impactor Adaptor #1 | PRIMA | LIMACORPORATE SPA |
20 | 08033390216463 | 9013.67.055 | 9013.67.055 | PRIMA - Metaphyseal Centering Guide - LEFT | PRIMA | LIMACORPORATE SPA |
21 | 08033390216456 | 9013.67.050 | 9013.67.050 | PRIMA - Metaphyseal Centering Guide - RIGHT | PRIMA | LIMACORPORATE SPA |
22 | 08033390216432 | 9013.67.147 | 9013.67.147 | PRIMA - Impactor Adaptor #7 | PRIMA | LIMACORPORATE SPA |
23 | 08033390216401 | 9013.67.145 | 9013.67.145 | PRIMA - Impactor Adaptor #5 | PRIMA | LIMACORPORATE SPA |
24 | 08033390216395 | 9013.67.144 | 9013.67.144 | PRIMA - Impactor Adaptor #4 | PRIMA | LIMACORPORATE SPA |
25 | 08033390216333 | 9013.67.143 | 9013.67.143 | PRIMA - Impactor Adaptor #3 | PRIMA | LIMACORPORATE SPA |
26 | 08033390216326 | 9013.67.142 | 9013.67.142 | PRIMA - Impactor Adaptor #2 | PRIMA | LIMACORPORATE SPA |
27 | 08033390215763 | 9013.74.151 | 9013.74.151 | SMR - Ecc. Glenosphere Orienter 42mm | SMR Shoulder | LIMACORPORATE SPA |
28 | 08033390215756 | 9013.74.150 | 9013.74.150 | SMR - Glenosphere Orienter 42mm | SMR Shoulder | LIMACORPORATE SPA |
29 | 08033390214797 | 9013.67.020 | 9013.67.020 | PRIMA - Humeral Starting Awl | PRIMA | LIMACORPORATE SPA |
30 | 08033390214599 | 9013.79.583 | 9013.79.583 | SMR Shoulder - Glenosph. Dia. 42-Ecc.42 Extract. Insert | SMR Shoulder | LIMACORPORATE SPA |
31 | 08033390214582 | 9013.67.435 | 9013.67.435 | PRIMA - Cemented Axial reamer #6-7 | PRIMA | LIMACORPORATE SPA |
32 | 08033390214575 | 9013.67.427 | 9013.67.427 | PRIMA - Cemented Axial reamer guide #7 | PRIMA | LIMACORPORATE SPA |
33 | 08033390214568 | 9013.67.426 | 9013.67.426 | PRIMA - Cemented Axial reamer guide #6 | PRIMA | LIMACORPORATE SPA |
34 | 08033390214537 | 9013.67.430 | 9013.67.430 | PRIMA - Cemented Axial reamer #1-5 | PRIMA | LIMACORPORATE SPA |
35 | 08033390213646 | 9013.67.407 | 9013.67.407 | PRIMA - Metaphyseal Removal Reamer #7 | PRIMA | LIMACORPORATE SPA |
36 | 08033390213639 | 9013.67.406 | 9013.67.406 | PRIMA - Metaphyseal Removal Reamer #6 | PRIMA | LIMACORPORATE SPA |
37 | 08033390213622 | 9013.67.405 | 9013.67.405 | PRIMA - Metaphyseal Removal Reamer #5 | PRIMA | LIMACORPORATE SPA |
38 | 08033390213615 | 9013.67.404 | 9013.67.404 | PRIMA - Metaphyseal Removal Reamer #4 | PRIMA | LIMACORPORATE SPA |
39 | 08033390213608 | 9013.67.403 | 9013.67.403 | PRIMA - Metaphyseal Removal Reamer #3 | PRIMA | LIMACORPORATE SPA |
40 | 08033390213592 | 9013.67.402 | 9013.67.402 | PRIMA - Metaphyseal Removal Reamer #2 | PRIMA | LIMACORPORATE SPA |
41 | 08033390213585 | 9013.67.401 | 9013.67.401 | PRIMA - Metaphyseal Removal Reamer #1 | PRIMA | LIMACORPORATE SPA |
42 | 08033390213554 | 9013.67.001 | 9013.67.001 | PRIMA - Humeral Starting Awl | PRIMA | LIMACORPORATE SPA |
43 | 08033390213547 | 9013.67.425 | 9013.67.425 | PRIMA - Cemented Axial reamer guide #5 | PRIMA | LIMACORPORATE SPA |
44 | 08033390213530 | 9013.67.424 | 9013.67.424 | PRIMA - Cemented Axial reamer guide #4 | PRIMA | LIMACORPORATE SPA |
45 | 08033390213523 | 9013.67.423 | 9013.67.423 | PRIMA - Cemented Axial reamer guide #3 | PRIMA | LIMACORPORATE SPA |
46 | 08033390213516 | 9013.67.422 | 9013.67.422 | PRIMA - Cemented Axial reamer guide #2 | PRIMA | LIMACORPORATE SPA |
47 | 08033390213509 | 9013.67.421 | 9013.67.421 | PRIMA - Cemented Axial reamer guide #1 | PRIMA | LIMACORPORATE SPA |
48 | 08033390204576 | 1365.54.820 | 1365.54.820 | SMR Shoulder - Reverse Liner +6 mm Dia. 40 mm - LIMAVIT | SMR Shoulder | LIMACORPORATE SPA |
49 | 08033390204576 | 1365.54.820 | 1365.54.820 | SMR Shoulder - Reverse Liner +6 mm Dia. 40 mm - LIMAVIT | SMR Shoulder | LIMACORPORATE SPA |
50 | 08033390204569 | 1365.54.816 | 1365.54.816 | SMR Shoulder - Reverse Liner Retentive +3 mm Dia. 40 mm - LIMAVIT | SMR Shoulder | LIMACORPORATE SPA |