No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10705034543826 | 698343977 | 698343977 | MODIFIED INSTRUMENT STAPLE IMPACTOR | HWA | IMPACTOR | 1 | NA |
2 | 10705034471716 | 698341171 | MODIFIED INSTRUMENT ROD HOLDER WITH STOPS | LXH | Orthopedic manual surgical instrument | 1 | NA | |
3 | 10705034459639 | 698339626 | 698339626 | MODIFIED INSTRUMENT DRILL STOP | FZX | Guide, surgical, instrument | 1 | NA |
4 | 10705034452920 | 698336506 | MODIFIED INSTRUMENT OSTEOTOME | HWM | OSTEOTOME | 1 | NA | |
5 | 10705034374871 | 698336725 | 698336725 | MODIFIED INSTRUMENT TAP 14mm | HWX | TAP, BONE | 1 | NA |
6 | 10705034341798 | SPB400 | SPB400 | SURGICAL POSITIONING BOARD POST SET | JEB | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL | 1 | NA |
7 | 10705034240602 | 2029T | 2029T | SPINAL INSTRUMENT INSTRUMENT CASE | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | NA |
8 | 10705034236636 | 6300000030 | 6300000030 | AETI SYSTEM CURETTE-0000 x 30 DEGREE | HTF | CURETTE | 1 | NA |
9 | 10705034007397 | 6300214 | 6300214 | AETI SYSTEM DISC SHAVER 13 x 15mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
10 | 10705034007359 | 6300206 | 6300206 | AETI SYSTEM DISC SHAVER 5 x 7mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
11 | 10705034201252 | 279782115 | 279782115 | EXPEDIUM SPINE SYSTEM ROD TRAY 5.5 | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | EXPEDIUM |
12 | 10705034188584 | 273330105 | 273330105 | BENGAL SYSTEM TRIAL, STANDARD 5 | HWT | TEMPLATE | 1 | BENGAL |
13 | 10705034188652 | 273330205 | 273330205 | BENGAL SYSTEM TRIAL, LARGE 5 | HWT | TEMPLATE | 1 | BENGAL |
14 | 10705034192536 | 274586000 | 274586000 | MOSS MIAMI SPINE SYSTEM SCREWDRIVER | HWR | DRIVER, PROSTHESIS | 1 | MOSS |
15 | 10705034192475 | 274579000 | 274579000 | MOSS MIAMI SPINE SYSTEM ROD CUTTER | HTZ | INSTRUMENT, CUTTING, ORTHOPEDIC | 1 | MOSS |
16 | 10705034189918 | 273500200 | 273500200 | UNIVERSAL ALIF INSERTION INSTRUMENT SET | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | ALIF |
17 | 10705034187723 | 273215000 | 273215000 | COUGAR SYSTEM 15 DEGREES CADDY | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | COUGAR |
18 | 10705034186351 | 273121001 | 273121001 | PLIF SG INSTRUMENTS TRIAL INSERTER | HWR | DRIVER, PROSTHESIS | 1 | PLIF |
19 | 10705034185330 | 272804000 | 272804000 | BOWTI ANTERIOR BUTTRESS STAPLE CASE AND TRAY | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | BOWTI |
20 | 10705034184944 | 272320050 | 272320050 | APERTURE SPINAL ACCESS SYSTEM AWL | HWJ | AWL | 1 | NA |
21 | 10705034139029 | 187703450 | 187703450 | EXPEDIUM ANTERIOR SPINE SYSTEM ROD 5.5 x 450mm | KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | 2 | EXPEDIUM |
22 | 10705034004068 | 2028812 | 2028812 | PLIG SYSTEM DISC SHAVER 12mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
23 | 10705034004051 | 2028811 | 2028811 | PLIG SYSTEM DISC SHAVER 11mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
24 | 10705034004013 | 2028807 | 2028807 | PLIG SYSTEM DISC SHAVER 7mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
25 | 10705034077284 | 179762030 | 179762030 | MOSS MIAMI SPINE SYSTEM ROD 5.5 x 30mm | KWQ,MNH,KWP | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spin APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spinal fixation,APPLIANCE, FIXATION, SPINAL INTERLAMINAL | 2 | MOSS |
26 | 10705034051536 | 176804312 | 176804312 | SURGICAL TITANIUM MESH ENDCAP 12 x 23mm | EZX | Mesh, surgical, metal | 2 | NA |
27 | 10705034001135 | 204206 | 204206 | SPINAL INSTRUMENT SIDE CURETTE LEFT HAND | HTF | CURETTE | 1 | NA |
28 | 10705034570402 | 698344682 | 698344682 | MODIFIED INSTRUMENT TRIAL DRILL GUIDE | FZX | Guide, surgical, instrument | 1 | NA |
29 | 10705034564661 | 698344241 | 698344241 | MODIFIED INSTRUMENT DRIVER | HXX | SCREWDRIVER | 1 | NA |
30 | 10705034570723 | 698344727 | 698344727 | MODIFIED INSTRUMENT ADJACENT LEVEL REDUCER, PUSHER | LXH | Orthopedic manual surgical instrument | 1 | NA |
31 | 10705034570693 | 698344731 | 698344731 | MODIFIED INSTRUMENT LEVER LOCK CLAMP | LXH | Orthopedic manual surgical instrument | 1 | NA |
32 | 10705034570686 | 698344694 | 698344694 | MODIFIED INSTRUMENT DISTRACTOR | GDI | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 1 | NA |
33 | 10705034570662 | 698344681 | 698344681 | MODIFIED INSTRUMENT CANNULATED PROBE | HXB | PROBE | 1 | NA |
34 | 10705034570655 | 698344680 | 698344680 | MODIFIED INSTRUMENT SPREADER 12mm | LXH | Orthopedic manual surgical instrument | 1 | NA |
35 | 10705034570624 | 698344728 | 698344728 | MODIFIED INSTRUMENT ADJACENT LEVEL REDUCER, JOYSTICK | LXH | Orthopedic manual surgical instrument | 1 | NA |
36 | 10705034570600 | 698344716 | 698344716 | MODIFIED INSTRUMENT CURETTE 8mm | HTF | CURETTE | 1 | NA |
37 | 10705034570594 | 698344714 | 698344714 | MODIFIED INSTRUMENT DISTRACTOR, 6.35mm | GDI | DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 1 | NA |
38 | 10705034570518 | 698344719 | 698344719 | MODIFIED INSTRUMENT DRILL GUIDE | FZX | Guide, surgical, instrument | 1 | NA |
39 | 10705034570501 | 698344732 | 698344732 | MODIFIED INSTRUMENT LEVER LOCK INSERTER | LXH | Orthopedic manual surgical instrument | 1 | NA |
40 | 10705034569970 | 698344674 | 698344674 | MODIFIED INSTRUMENT SPREADER 6mm | LXH | Orthopedic manual surgical instrument | 1 | NA |
41 | 10705034570433 | 698344726 | 698344726 | MODIFIED INSTRUMENT ADJACENT LEVEL REDUCER, CLIP | LXH | Orthopedic manual surgical instrument | 1 | NA |
42 | 10705034570396 | 698344729 | 698344729 | MODIFIED INSTRUMENT REDUCER, LEFT | LXH | Orthopedic manual surgical instrument | 1 | NA |
43 | 10705034570389 | 698344686 | 698344686 | MODIFIED INSTRUMENT REDUCTION SLEEVE | LXH | Orthopedic manual surgical instrument | 1 | NA |
44 | 10705034570310 | 698344691 | 698344691 | MODIFIED INSTRUMENT RASP 55mm X 18mm | HWT | TEMPLATE | 1 | NA |
45 | 10705034570280 | 698344722 | 698344722 | MODIFIED INSTRUMENT REUSABLE JAMSHIDI | GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | 1 | NA |
46 | 10705034570273 | 698344703 | 698344703 | MODIFIED INSTRUMENT HANDLE | GDZ | HANDLE, SCALPEL | 1 | NA |
47 | 10705034570266 | 698344677 | 698344677 | MODIFIED INSTRUMENT SPREADER 9mm | LXH | Orthopedic manual surgical instrument | 1 | NA |
48 | 10705034570242 | 698344688 | 698344688 | MODIFIED INSTRUMENT ROD HOLDER 5.5mm | LXH | Orthopedic manual surgical instrument | 1 | NA |
49 | 10705034570228 | 698344734 | 698344734 | MODIFIED INSTRUMENT LEVER LOCK KNOB | LXH | Orthopedic manual surgical instrument | 1 | NA |
50 | 10705034570211 | 698344724 | 698344724 | MODIFIED INSTRUMENT QCK-CONNECT DRIVER X25 | HXX | SCREWDRIVER | 1 | NA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07613327064797 | 2102-2305 | 2102-2305 | Bone graft substitute | Vitoss BA Injectable | STRYKER ORTHOBIOLOGICS |
2 | 07613327064780 | 2102-2302 | 2102-2302 | Bone graft substitute | Vitoss BA Injectable | STRYKER ORTHOBIOLOGICS |
3 | 07613327064773 | 2102-2301 | 2102-2301 | Bone graft substitute | Vitoss BA Injectable | STRYKER ORTHOBIOLOGICS |
4 | 07613327064292 | 897015 | 897015 | Injectable HA Bone Cement | HydroSet XT | STRYKER CORPORATION |
5 | 07613327064285 | 897010 | 897010 | Injectable HA Bone Cement | HydroSet XT | STRYKER CORPORATION |
6 | 07613327064278 | 897005 | 897005 | Injectable HA Bone Cement | HydroSet XT | STRYKER CORPORATION |
7 | 07613327064261 | 897003 | 897003 | Injectable HA Bone Cement | HydroSet XT | STRYKER CORPORATION |
8 | 07610221014095 | 500500 | - | Orthoss® | GEISTLICH PHARMA AG | |
9 | 07610221013142 | 500499 | - | Orthoss® | GEISTLICH PHARMA AG | |
10 | 07610221013135 | 500498 | - | - | Orthoss® | GEISTLICH PHARMA AG |
11 | 07610221013128 | 500497 | - | Orthoss® | GEISTLICH PHARMA AG | |
12 | 07610221013111 | 500502 | - | Orthoss® | GEISTLICH PHARMA AG | |
13 | 07610221013104 | 500501 | - | Orthoss® | GEISTLICH PHARMA AG | |
14 | 07350086550726 | 2.5cc | OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075) | OssDsign Catalyst | OSSDSIGN AB | |
15 | 07350086550719 | 5cc | 104050 | OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075) | OssDsign Catalyst | OSSDSIGN AB |
16 | 07350086550702 | 10cc | 104100 | OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075) | OssDsign Catalyst | OSSDSIGN AB |
17 | 07350055430066 | A0210-11 | A0210-11 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
18 | 07350055430042 | A0210-09 | A0210-09 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
19 | 07350055430035 | A0210-08 | A0210-08 | CERAMENT™BONE VOID FILLER | BONE SUPPORT AB | |
20 | 06953122702304 | Gr-3 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
21 | 06953122702298 | Gr-2 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
22 | 06953122702281 | Gr-1 | Particles | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
23 | 06953122702274 | Re-7 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
24 | 06953122702267 | Re-6 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
25 | 06953122702250 | Re-5 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
26 | 06953122702243 | Re-4 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
27 | 06953122702236 | Re-3 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
28 | 06953122702212 | Re-2 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
29 | 06953122702205 | Re-1 | Block | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
30 | 06953122702199 | Co-5 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
31 | 06953122702182 | Co-4 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
32 | 06953122702175 | Co-3 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
33 | 06953122702168 | Co-2 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
34 | 06953122702151 | Co-1 | Cylinder | Bongold Bone Graft Material | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO., LTD. | |
35 | 06438408009730 | 1 | SGN-1500 | Morsels 1.5 cc / 1.5 ml | Ventris SIgnal™ | INION OY |
36 | 06438408009617 | 1 | BRS-1602 | Block 5 x 10 x 4 mm | Inion OTPS BioRestore™ | INION OY |
37 | 06438408009587 | 1 | BRS-5497 | Block, Large, Wedge 14 mm | Inion BioRestore™ Sahara | INION OY |
38 | 06438408009570 | 1 | BRS-5496 | Block, Large, Wedge 12 mm | Inion BioRestore™ Sahara | INION OY |
39 | 06438408009563 | 1 | BRS-5495 | Block, Large, Wedge 10 mm | Inion BioRestore™ Sahara | INION OY |
40 | 06438408009556 | 1 | BRS-5494 | Block, Large, Wedge 8 mm | Inion BioRestore™ Sahara | INION OY |
41 | 06438408009549 | 1 | BRS-5493 | Block, Large 14 mm | Inion BioRestore™ Sahara | INION OY |
42 | 06438408009532 | 1 | BRS-5492 | Block, Large 12 mm | Inion BioRestore™ Sahara | INION OY |
43 | 06438408009525 | 1 | BRS-5491 | Block, Large 10 mm | Inion BioRestore™ Sahara | INION OY |
44 | 06438408009518 | 1 | BRS-5490 | Block, Large 8 mm | Inion BioRestore™ Sahara | INION OY |
45 | 06438408009501 | 1 | BRS-5487 | Block, Standard, Wedge 14 mm | Inion BioRestore™ Sahara | INION OY |
46 | 06438408009495 | 1 | BRS-5486 | Block, Standard, Wedge 12 mm | Inion BioRestore™ Sahara | INION OY |
47 | 06438408009488 | 1 | BRS-5485 | Block, Standard, Wedge 10 mm | Inion BioRestore™ Sahara | INION OY |
48 | 06438408009471 | 1 | BRS-5484 | Block, Standard, Wedge 8 mm | Inion BioRestore™ Sahara | INION OY |
49 | 06438408009464 | 1 | BRS-5483 | Block, Standard 14 mm | Inion BioRestore™ Sahara | INION OY |
50 | 06438408009419 | 1 | BRS-5473 | Oval, Standard 7 mm | Inion BioRestore™ Sahara | INION OY |