No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00885556051375 | 71930717 | 71930717 | SYNERGY PC FEM SZ18 130MM | LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 2 | SYNERGY |
2 | 00885556799789 | 71075113B | 71075113B | SMART TSF FULL RING 130MM BLUE | KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | 2 | SMART TSF |
3 | 00885556765357 | E0016663-6 | E0016663-6 | HANDLE | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
4 | 00885556076538 | 913374 | 913374 | STAPLE 1.16X3.8X3.4 | JDR | STAPLE, FIXATION, BONE | 2 | NA |
5 | 00885556885208 | E0017815-2 | E0017815-2 | SHORTENED 180 2/3 RING | JDW | PIN, FIXATION, THREADED | 2 | Ex-Fix |
6 | 00885556883051 | E0017793-1 | E0017793-1 | MODIFIED META NAIL DROP | HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 2 | Meta Nail |
7 | 00885556867969 | E0017558-7 | E0017558-7 | FLEXIBLE I/M ROD | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Journey II |
8 | 00885556816721 | E0017448-3 | E0017448-3 | MODIFIED HEX DRIVER | HWR | DRIVER, PROSTHESIS | 1 | Polar |
9 | 00885556810484 | E0017443-1 | E0017443-1 | JII TIBIAL BLOCK - LEFT | FZX | Guide, surgical, instrument | 1 | JII |
10 | 00885556806326 | E0017367-11 | E0017367-11 | MODIFIED R3 INSERTER | JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 2 | R3 |
11 | 00885556805770 | E0017337-1 | E0017337-1 | JII FLEXION SPACER BLOCK | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | JII |
12 | 00885556804827 | E0017314-9 | E0017314-9 | AP BLOCK SZ 8 | FZX | Guide, surgical, instrument | 1 | Legion |
13 | 00885556802410 | E0017267-1 | E0017267-1 | TIBIAL STEM TRIAL - 10MM X 70MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | Legion |
14 | 00885556801673 | E0017241-1 | E0017241-1 | MIS DA X-BAR | JDG | Prosthesis, hip, femoral component, cemented, metal | 2 | R3 |
15 | 00885556800812 | E0017230-1 | E0017230-1 | 2MM RECUT BLOCK | HWT | TEMPLATE | 1 | Journey II |
16 | 00885556795255 | E0017150-1 | E0017150-1 | 11MM DEEP FLUTED END CUTTING REAMER | HTO | REAMER | 1 | Trigen |
17 | 00885556793893 | E0017119-7 | E0017119-7 | MIS ACETABULAR REAMER 58MM | HTO | REAMER | 1 | R3 |
18 | 00885556791905 | E0017091-2 | E0017091-2 | TIBIAL CUTTING BLOCK - RT | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
19 | 00885556790229 | E0017054-1 | E0017054-1 | MODULAR FIN PUNCH HANDLE | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | JII |
20 | 00885556783313 | E0016980-3 | E0016980-3 | UPPER TIBIAL GUIDE | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Journey II |
21 | 00885556777954 | E0016892-1 | E0016892-1 | 9MM REAMER HEAD | HTO | REAMER | 1 | Trigen |
22 | 00885556775103 | E0016853-3 | E0016853-3 | EXTENDED T8 DRIVER SHAFT | HXX | SCREWDRIVER | 1 | PERI-LOC |
23 | 00885556773673 | ROB20000 | ROB20000 | CORI ROBOTICS USA | OLO | Orthopedic stereotaxic instrument | 2 | Real Intelligence |
24 | 00885556771013 | E0016765-1 | E0016765-1 | MODIFIED ANGEL WING | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
25 | 00885556770566 | E0016753-1 | E0016753-1 | FLUTED CURVED CANNULATED AWL | HWJ | AWL | 1 | Trigen |
26 | 00885556763742 | 71170734 | 71170734 | EVOS LARGE PROXIMAL HUMERUS PLATE TRAY | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | EVOS |
27 | 00885556763155 | E0016528-7 | E0016528-7 | SZ 51MM BRIDGEBACK REAMER | HTO | REAMER | 1 | R3 |
28 | 00885556762189 | 72581004 | 72581004 | EVOS 3.5MM/4.5MM UTILITY PLATE 4H 147MM | HRS | Plate, fixation, bone | 2 | EVOS |
29 | 00885556757192 | E0016586-2 | E0016586-2 | 8.5MM REAMER HEAD | HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | 1 | Trigen |
30 | 00885556757116 | E0016583-1 | E0016583-1 | RAT TAIL RASP | JDG | Prosthesis, hip, femoral component, cemented, metal | 2 | Polar |
31 | 00885556755068 | ROB10000 | ROB10000 | CORI Starter Kit | OLO | Orthopedic stereotaxic instrument | 2 | CORI |
32 | 00885556753682 | E0016536-2 | E0016536-2 | ZUK SPACER BLOCK - 11MM | HWT | TEMPLATE | 1 | Uni |
33 | 00885556752081 | 72546585N | 72546585N | EVOS 6.5MM X 85MM CANNULATED SCREW | HWC | Screw, fixation, bone | 2 | EVOS |
34 | 00885556740422 | E0016327-2 | E0016327-2 | IM ROD SHORT | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | JII |
35 | 00885556737392 | E0016303-3 | E0016303-3 | OFFSET FIXATION ROD | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | JII |
36 | 00885556733837 | E0016253-2 | E0016253-2 | LARGE BLADE | GAD | RETRACTOR | 1 | Anthology |
37 | 00885556725337 | E0016116-2 | E0016116-2 | 2MM RECUT BLOCK | HWT | TEMPLATE | 1 | Legion |
38 | 00885556722701 | 21-8020 | 21-8020 | DEPTH GAGE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A |
39 | 00885556627020 | PFSI00040 | PFSI00040 | Stride Poly Insert Size D 9mm | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | STRIDE |
40 | 00885556716274 | E0015966-1 | E0015966-1 | FEMORAL STYLUS | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
41 | 00885556715536 | E0015722-1 | E0015722-1 | FEMORAL TRIAL PADDLE | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
42 | 00885556626979 | PFSI00033 | PFSI00033 | Stride Poly Insert Size C 8mm | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | STRIDE |
43 | 00885556713662 | 72411812 | 72411812 | EVOS 1.8MM X 12MM LOCKING PEG T7 | HRS | Plate, fixation, bone | 2 | EVOS |
44 | 00885556710357 | E0015809-1 | E0015809-1 | SIDE FEMORAL HEAD IMPACTOR | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | R3 |
45 | 00885556710418 | E0015860-1 | E0015860-1 | IM ALIGNMENT GUIDE WITH THUMB SCREWS | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
46 | 00885556710241 | E0015781-3 | E0015781-3 | SPIKED ELEVATOR - STRAIGHT | HTE | ELEVATOR | 1 | Peri-loc |
47 | 00885556708675 | E0015708-5 | E0015708-5 | GII PS TRIAL INSERT 5-6 9MM | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | Legion |
48 | 00885556706978 | E0015771-1 | E0015771-1 | 2MM RECUT BLOCK | HWT | TEMPLATE | 1 | Legion |
49 | 00885556704561 | E0015694-2 | E0015694-2 | PATELLA DEPTH GAUGE - 5MM | HRY | PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | Legion |
50 | 00885556704455 | E0015672-1 | E0015672-1 | JOURNEY CR FEMORAL IMPACTOR | JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 2 | Journey II |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M963IFS250 | IFS2.5 | IFS2.5 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 3ea K-wires with sharps protection, and 1ea Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
2 | M9632585S30 | 2585S3 | 2585S3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains; 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") double trocar k-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
3 | M9632585S20 | 2585S2 | 2585S2 | 'Product received FDA 510(k) clearance for: small bone fixation, reconstruction 'Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in place with a locking pin; 1ea 1.1mm (0.045") Double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
4 | M9632585L30 | 2585L3 | 2585L3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains; 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") double trocar k-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
5 | M9632565S30 | 2565S3 | 2565S3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin; 1ea 1.1mm (0.045") Double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
6 | M9632565L30 | 2565L3 | 2565L3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol IFS implant held in instrument with a locking pin, 1ea 1.1mm (0.045") double trocar K-wire with sharps protection, and 1ea 2.7mm Drill Bit with integral handle for manual use. | Intramedullary Fixation Scaffold (IFS) | METRIC MEDICAL DEVICES, INC. |
7 | M9632265L30 | 2265L3 | 2265L3 | Product received FDA 510(k) clearance for: small bone fixation, reconstruction a Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of findgers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol Intramedullary Fixation Scaffold (SuperScaffold™) implant held in place by use of a locking pin; 1ea 1.1mm (0.045") double trocar K-wire with sharps protection, and 1ea 2.2mm Drill Bit with integral handle for manual use. | SuperScaffold™ | METRIC MEDICAL DEVICES, INC. |
8 | M7557923181 | gS 79.2316 | gS 79.2316 | K-Wire D. Trocar 6" 1.6mm [.062"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
9 | M7557923161 | gS 79.2318 | gS 79.2318 | K-Wire D. Trocar 6" 1.8mm [.070"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
10 | M7557923160 | gS 79.2316 | gS 79.2316 | K-Wire D. Trocar 6" 1.6mm [.062"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
11 | M7557923151 | gS 79.2315 | gS 79.2315 | K-Wire D. Trocar 6" 1.5mm [.059"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
12 | M7557923150 | gS 79.2315 | gS 79.2315 | K-Wire D. Trocar 6" 1.5mm [.059"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
13 | M7557923121 | gS 79.2312 | gS 79.2312 | K-Wire D. Trocar 6" 1.2mm [.047"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
14 | M7557923120 | gS 79.2312 | gS 79.2312 | K-Wire D. Trocar 6" 1.2mm [.047"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
15 | M7557923101 | gS 79.2310 | gS 79.2310 | K-Wire D. Trocar 6" 1.0mm [.039"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
16 | M7557923100 | gS 79.2310 | gS 79.2310 | K-Wire D. Trocar 6" 1.0mm [.039"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
17 | M7557923061 | gS 79.2306 | gS 79.2306 | K-Wire D. Trocar 6" 0.6mm [.024"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
18 | M7557923060 | gS 79.2306 | gS 79.2306 | K-Wire D. Trocar 6" 0.6mm [.024"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
19 | M7557921181 | gS 79.2118 | gS 79.2118 | K-Wire D. Trocar 4" 1.8mm [.070"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
20 | M7557921180 | gS 79.2118 | gS 79.2118 | K-Wire D. Trocar 4" 1.8mm [.070"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
21 | M7557921161 | gS 79.2116 | gS 79.2116 | K-Wire D. Trocar 4" 1.6mm [.062"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
22 | M7557921160 | gS 79.2116 | gS 79.2116 | K-Wire D. Trocar 4" 1.6mm [.062"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
23 | M7557921151 | gS 79.2115 | gS 79.2115 | K-Wire D. Trocar 4" 1.5mm [.059"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
24 | M7557921150 | gS 79.2115 | gS 79.2115 | K-Wire D. Trocar 4" 1.5mm [.059"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
25 | M7557921121 | gS 79.2112 | gS 79.2112 | K-Wire D. Trocar 4" 1.2mm [.047"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
26 | M7557921120 | gS 79.2112 | gS 79.2112 | K-Wire D. Trocar 4" 1.2mm [.047"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
27 | M7557921101 | gS 79.2110 | gS 79.2110 | K-Wire D. Trocar 4" 1.0mm [.039"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
28 | M7557921100 | gS 79.2110 | gS 79.2110 | K-Wire D. Trocar 4" 1.0mm [.039"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
29 | M7557921061 | gS 79.2106 | gS 79.2106 | K-Wire D. Trocar 4" 0.6mm [.024"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
30 | M7557921060 | gS 79.2106 | gS 79.2106 | K-Wire D. Trocar 4" 0.6mm [.024"] Ti Alloy pkg/1 | gSource | GSOURCE LLC |
31 | M7557884801 | gS 78.8480 | Stein. Pin D. Diam Thr. 9" 4.5mm [.177"] pkg/6 | gSource | GSOURCE LLC | |
32 | M7557884800 | gS 78.8480 | gS 78.8480 | Stein. Pin D. Diam Thr. 9" 4.5mm [.177"] pkg/6 | gSource | GSOURCE LLC |
33 | M7557883300 | gS 78.8330 | gS 78.8330 | Stein. Pin D. Diam Thr. 9" 2.4mm [.094"] pkg/6 | gSource | GSOURCE LLC |
34 | M7557883001 | gS 78.8300 | Stein. Pin D. Diam Thr. 9" 2.0mm [.079"] pkg/6 | gSource | GSOURCE LLC | |
35 | M7557883000 | gS 78.8300 | gS 78.8300 | Stein. Pin D. Diam Thr. 9" 2.0mm [.079"] pkg/6 | gSource | GSOURCE LLC |
36 | M7557879401 | gS 78.7940 | Stein. Pin S. Troc Rd 12" 4.0mm [.157"] pkg/6 | gSource | GSOURCE LLC | |
37 | M7557879400 | gS 78.7940 | gS 78.7940 | Stein. Pin S. Troc Rd 12" 4.0mm [.157"] pkg/6 | gSource | GSOURCE LLC |
38 | M7557878001 | gS 78.7800 | Stein. Pin S. Troc Rd 12" 3.2mm [.126"] pkg/6 | gSource | GSOURCE LLC | |
39 | M7557878000 | gS 78.7800 | gS 78.7800 | Stein. Pin S. Troc Rd 12" 3.2mm [.126"] pkg/6 | gSource | GSOURCE LLC |
40 | M7557877820 | gS 78.7782 | gS 78.7782 | Stein. Pin S. Diam Rd 9" 4.5mm [.177"] pkg/6 | gSource | GSOURCE LLC |
41 | M7557877801 | gS 78.7780 | Stein. Pin S. Diam Rd 9" 2.0mm [.079"] pkg/6 | gSource | GSOURCE LLC | |
42 | M7557877800 | gS 78.7780 | gS 78.7780 | Stein. Pin S. Diam Rd 9" 2.0mm [.079"] pkg/6 | gSource | GSOURCE LLC |
43 | M7557877501 | gS 78.7750 | Stein. Pin S. Diam Rd 9" 4.0mm [.157"] pkg/6 | gSource | GSOURCE LLC | |
44 | M7557877500 | gS 78.7750 | gS 78.7750 | Stein. Pin S. Diam Rd 9" 4.0mm [.157"] pkg/6 | gSource | GSOURCE LLC |
45 | M7557877201 | gS 78.7720 | Stein. Pin S. Diam Rd 9" 3.5mm [.138"] pkg/6 | gSource | GSOURCE LLC | |
46 | M7557877200 | gS 78.7720 | gS 78.7720 | Stein. Pin S. Diam Rd 9" 3.5mm [.138"] pkg/6 | gSource | GSOURCE LLC |
47 | M7557876901 | gS 78.7690 | K-Wire S. Trocar 4" 1.4mm [.054"] pkg/6 | gSource | GSOURCE LLC | |
48 | M7557876900 | gS 78.7690 | gS 78.7690 | K-Wire S. Trocar 4" 1.4mm [.054"] pkg/6 | gSource | GSOURCE LLC |
49 | M7557876601 | gS 78.7660 | Stein. Pin S. Diam Rd 9" 2.8mm [.110"] pkg/6 | gSource | GSOURCE LLC | |
50 | M7557876600 | gS 78.7660 | gS 78.7660 | Stein. Pin S. Diam Rd 9" 2.8mm [.110"] pkg/6 | gSource | GSOURCE LLC |