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 | 03760154007924 | Screw for OTIS-C PLUS plate fixation | EVO9066080 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
2 | 03760154004770 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66027 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
3 | 03760154004732 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66030 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
4 | 03760154004718 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66050 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
5 | 03760154004701 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66036 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
6 | 03760154004695 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66033 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
7 | 03760154004497 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66055 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
8 | 03760154004480 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66065 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
9 | 03760154004459 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66039 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
10 | 03760154004190 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66060 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
11 | 03760154004169 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66042 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
12 | 03760154004152 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66070 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS p NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | OTIS-C PLUS | S.B.M |
13 | 03760154004145 | NON STERILE Screw for OTIS-C PLUS plate fixation | EVONS66045 | NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
14 | 03760154001397 | Screw for OTIS-C PLUS plate fixation | EVO9066075 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
15 | 03760154001281 | Screw for OTIS-C PLUS plate fixation | EVO9066070 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
16 | 03760154001274 | Screw for OTIS-C PLUS plate fixation | EVO9066065 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
17 | 03760154001267 | Screw for OTIS-C PLUS plate fixation | EVO9066060 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
18 | 03760154001250 | Screw for OTIS-C PLUS plate fixation | EVO9066055 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
19 | 03760154001243 | Screw for OTIS-C PLUS plate fixation | EVO9066050 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
20 | 03760154001236 | Screw for OTIS-C PLUS plate fixation | EVO9066045 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
21 | 03760154001229 | Screw for OTIS-C PLUS plate fixation | EVO9066042 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
22 | 03760154001212 | Screw for OTIS-C PLUS plate fixation | EVO9066039 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
23 | 03760154001205 | Screw for OTIS-C PLUS plate fixation | EVO9066036 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
24 | 03760154001199 | Screw for OTIS-C PLUS plate fixation | EVO9066033 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
25 | 03760154001182 | Screw for OTIS-C PLUS plate fixation | EVO9066030 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
26 | 03760154001175 | Screw for OTIS-C PLUS plate fixation | EVO9066027 | 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. | OTIS-C PLUS | S.B.M |
27 | 03701337609993 | S80 ST335 | I.B.S™ | IN2BONES | ||
28 | 03701337609986 | S80 ST325 | I.B.S™ | IN2BONES | ||
29 | 03701337606381 | S25 ST011 | I.B.S™ | IN2BONES | ||
30 | 03701337605513 | S27 ST020 B | Snap-off screw titanium | IBS™ | IN2BONES | |
31 | 03701337605506 | S27 ST018 B | Snap-off screw titanium | IBS™ | IN2BONES | |
32 | 03701337605490 | S27 ST016 B | Snap-off screw titanium | IBS™ | IN2BONES | |
33 | 03701337605483 | S27 ST014 B | Snap-off screw titanium | IBS™ | IN2BONES | |
34 | 03701337605476 | S27 ST013 B | Snap-off screw titanium | IBS™ | IN2BONES | |
35 | 03701337605469 | S27 ST012 B | Snap-off screw titanium | IBS™ | IN2BONES | |
36 | 03701337605452 | S27 ST011 B | Snap-off screw titanium | IBS™ | IN2BONES | |
37 | 03701337605339 | S22 ST014 B | Snap-off screw titanium | IBS™ | IN2BONES | |
38 | 03701337605322 | S22 ST013 B | Snap-off screw titanium | IBS™ | IN2BONES | |
39 | 03701337605315 | S22 ST012 B | Snap-off screw titanium | IBS™ | IN2BONES | |
40 | 03701337605308 | S22 ST011 B | Snap-off screw titanium | IBS™ | IN2BONES | |
41 | 03701337605292 | S22 ST010 B | Snap-off screw titanium | IBS™ | IN2BONES | |
42 | 03701337605285 | S22 ST009 B | Snap-off screw titanium | IBS™ | IN2BONES | |
43 | 03701337603137 | A60 SP174 B | Interphalangeal implants | DuaFit® | IN2BONES | |
44 | 03701337603120 | A60 SP173 B | Interphalangeal implants | DuaFit® | IN2BONES | |
45 | 03701337603113 | A60 SP172 B | Interphalangeal implants | DuaFit® | IN2BONES | |
46 | 03701337603106 | A60 SP171 B | Interphalangeal implants | DuaFit® | IN2BONES | |
47 | 03701337603090 | A60 SP104 B | Interphalangeal implants | DuaFit® | IN2BONES | |
48 | 03701337603083 | A60 SP103 B | Interphalangeal implants | DuaFit® | IN2BONES | |
49 | 03701337603076 | A60 SP102 B | Interphalangeal implants | DuaFit® | IN2BONES | |
50 | 03701337603069 | A60 SP101 B | Interphalangeal implants | DuaFit® | IN2BONES |