Panels › Orthopedic › Product code KTT · Class 2
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation 888.3030
9510(k)s in 12 months (405 all time)
11recalls in 12 months (89 all time)
85recalls that name a 510(k)
Top companies in KTT
| Company | 510(k)s | Recalls |
|---|---|---|
| Ebi, L.P. | 36 | 2 |
| Synthes | 33 | 1 |
| Stryker Corp. | 11 | 15 |
| Orthofix Srl | 11 | 12 |
| Howmedica Corp. | 22 | 0 |
| Howmedica Osteonics Corp. | 19 | 1 |
| Zimmer, Inc. | 10 | 9 |
| Smith & Nephew | 16 | 0 |
| Wrightmedicaltechnologyinc | 11 | 0 |
| Alliance Medical Corp. | 9 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 1999 | K993649 | EBI XFIX DFS WRISTFIX SYSTEM Ebi, L.P. | KTT |
| Aug 19, 1999 | K991941 | EBI XFIX DFS RAIL SYSTEM Electro-Biology, Inc. | KTT |
| Aug 17, 1999 | K992515 | EBI XFIX DFS OPTIROM ELBOW FIXATOR Ebi, L.P. | KTT |
| Aug 6, 1999 | K991806 | VHS SUPRACONDYLAR PLATE SYSTEM Walter Abendschein, M.D. | KTT |
| Mar 2, 1999 | K984364 | SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 Syntec Scientific Corp., TW | KTT |
| Feb 18, 1999 | K984498 | SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM Synthes (Usa) | KTT |
| Dec 30, 1998 | K983873 | SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM Syntec Scientific Corp., TW | KTT |
| Jul 8, 1998 | K981483 | EBI DFS JOINT FIXATOR, MODEL 02800 Electro-Biology, Inc. | KTT |
| Apr 14, 1998 | K980370 | BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR Biomet, Inc. | KTT |
| Feb 19, 1998 | K974409 | FRIEDL GLIDING NAIL SYSTEM Plus Orthopedics | KTT |
| Feb 18, 1998 | K974537 | SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM Synthes (Usa) | KTT |
| Nov 20, 1997 | K973321 | HOFFMANN II COMPACT PERIARTICULAR CLAMP Howmedica, Inc. | KTT |
| Nov 20, 1997 | K973231 | THE CORIFIX DYNAMIC HIP SCREW SYSTEM Corin USA | KTT |
| Nov 12, 1997 | K971993 | ODI COMPRESSION HIP SCREW SYSTEM Orthopaedic Designs, Inc. | KTT |
| Oct 16, 1997 | K973017 | SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP Synthes (Usa) | KTT |
| Oct 16, 1997 | K964880 | VARI-ANGLE HIP SCREW (VHS) SYSTEM Walter Abendschein, M.D. | KTT |
| Oct 9, 1997 | K972629 | DEPUY AE TK2 HIP SCREW SYSTEM Depuy, Inc. | KTT |
| May 9, 1997 | K970748 | TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM Smith & Nephew, Inc., Orthopaedic Div. | KTT |
| Apr 28, 1997 | K964400 | ALPHATEC EXTERNAL FIXATION SYSTEM Alphatec Mfg., Inc. | KTT |
| Apr 1, 1997 | K970290 | EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM Ebi, L.P. | KTT |
| Jan 22, 1997 | K962251 | MEDOFF SLIDING PLATE (PROPOSED NAME) Wrightmedicaltechnologyinc | KTT |
| Dec 9, 1996 | K964458 | ELLIS EXTERNAL MINI-FIXATOR SYSTEM Link America, Inc. | KTT |
| Nov 27, 1996 | K964094 | MINIFIX Ferguson Medical | KTT |
| Sep 5, 1996 | K962484 | SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) Synthes (Usa) | KTT |
| Aug 19, 1996 | K962808 | ILIZAROV EXTERNAL FIXATION SYSTEM Smith & Nephew Richards, Inc. | KTT |
| Jun 28, 1996 | K961433 | EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS Electro-Biology, Inc. | KTT |
| Jun 28, 1996 | K961350 | SYNTHES MINI EXTERNAL FIXATOR Synthes (Usa) | KTT |
| Jun 13, 1996 | K961213 | ALTA DOME AND PLUNGER (MEC HIP BOLT) Howmedica Corp. | KTT |
| Apr 10, 1996 | K955306 | OMEGA+ COMPRESSION SCREW SYSTEM Howmedica Corp. | KTT |
| Mar 18, 1996 | K960014 | PRACTIFIX EXTERNAL FIXATION SYSTEM Orthopaedic Innovations, Inc. | KTT |
| Jan 26, 1996 | K954555 | VERSA-FX FEMORAL FIXATION SYSTEM Zimmer, Inc. | KTT |
| Oct 31, 1995 | K954712 | INTRAMEDULLARY HIP SCREW (MODIFICATION) Smith & Nephew Richards, Inc. | KTT |
| Oct 31, 1995 | K953406 | EBI X FIX DYNAFIX SYSTEM (DFS) Electro-Biology, Inc. | KTT |
| Jul 13, 1995 | K951809 | GLIDING NAIL Encore Orthopedics, Inc. | KTT |
| Jun 21, 1995 | K951357 | EBI SMALL EXTERNAL FIXATOR (S/E/F/) Electro-Biology, Inc. | KTT |
| May 3, 1995 | K946156 | DEPUY COMPRESSION HIP SCREW SYSTEM Depuy, Inc. | KTT |
| Feb 1, 1995 | K945233 | PEDIATRIC OSTEOTOMY SYSTEM Howmedica Corp. | KTT |
| Jan 18, 1995 | K930836 | HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM Howmedica Corp. | KTT |
| Nov 28, 1994 | K944883 | GAMMA LOCKING NAIL - LONG LENGTH Howmedica Corp. | KTT |
| Sep 28, 1994 | K926417 | ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW Alphatec Mfg., Inc. | KTT |
| Mar 14, 1994 | K940286 | GAMMA LOCKING NAIL MODIFICATION Howmedica, Inc. | KTT |
| Mar 10, 1994 | K925460 | SYNTHES STERILE PINLESS EXTERNAL FIXATOR Synthes (Usa) | KTT |
| Mar 7, 1994 | K932174 | GAMMA LOCKING NAIL-CROSS LOCKING SCREWS Howmedica Corp. | KTT |
| Feb 22, 1994 | K930156 | MEGA PLUS SUPER LAG SCREW Pfizer Hospital Products Group, Inc. | KTT |
| Oct 4, 1993 | K923032 | FIXEL EXTERNAL FIXATION DEVICE Amp, Inc. | KTT |
| Oct 1, 1993 | K915599 | CAP WASHER ASSEMBLY Howmedica Corp. | KTT |
| Mar 22, 1993 | K925127 | ALTA CANCELLOUS BONE SCREW Howmedica Corp. | KTT |
| Nov 25, 1992 | K910993 | MORREY ELBOW FIXATOR Howmedica Corp. | KTT |
| Sep 8, 1992 | K922295 | OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION Howmedica Corp. | KTT |
| Jul 17, 1992 | K921786 | INTRAMEDULLARY HIP SCREW Smith & Nephew Richards, Inc. | KTT |
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