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 |
|---|---|---|---|
| Feb 3, 2003 | K023714 | REPROCESSED EXTERNAL FIXATION DEVICE Alliance Medical Corp. | KTT |
| Jan 28, 2003 | K023851 | PRECIMED HIP SCREW SYSTEM Precimed, Inc. | KTT |
| Jan 23, 2003 | K023941 | SYNTHES TOMOFIX OSTEOTOMY SYSTEM Synthes (Usa) | KTT |
| Jan 22, 2003 | K024248 | MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM Ebi, L.P. | KTT |
| Jan 15, 2003 | K024129 | MODIFICATION TO EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Oct 25, 2002 | K023399 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Oct 18, 2002 | K023324 | MODIFICATION TO EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Oct 18, 2002 | K023314 | MICROFIX Fixano SA | KTT |
| Sep 23, 2002 | K022771 | TWIN FIX Fixano SA | KTT |
| Sep 17, 2002 | K022423 | EXTERNAL FIXATION RING Rigid FX Orthopedics, Incorporated | KTT |
| Aug 26, 2002 | K021933 | TEMPFIX EXTERNAL FIXATION SYSTEM DePuy Orthopaedics, Inc. | KTT |
| Aug 12, 2002 | K022319 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Jun 24, 2002 | K012648 | REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES Alliance Medical Corp. | KTT |
| Jun 24, 2002 | K012623 | REPROCESSED EXTERNAL FIXATION DEVICE Alliance Medical Corp. | KTT |
| Jun 20, 2002 | K021695 | EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM Ebi, L.P. | KTT |
| Jun 5, 2002 | K020772 | OMEGA II SYSTEM Howmedica Osteonics Corp. | KTT |
| May 23, 2002 | K021312 | EBI DFS OPTIROM ELBOW FIXATOR Ebi, L.P. | KTT |
| May 16, 2002 | K021031 | EBI XFIX RAIL SYSTEM Ebi, L.P. | KTT |
| May 3, 2002 | K021091 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Apr 29, 2002 | K020311 | CLEARVIEW WRIST FIXATOR Rigid FX Orthopedics, Incorporated | KTT |
| Mar 8, 2002 | K020403 | MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR Ebi, L.P. | KTT |
| Mar 4, 2002 | K012294 | WRISTORE FIXATOR Millennium Medical Technologies, Inc. | KTT |
| Mar 1, 2002 | K014276 | MODIFICATION TO EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Feb 22, 2002 | K020240 | SLIM GLIDING NAIL SYSTEM Plus Orthopedics | KTT |
| Feb 5, 2002 | K020141 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. | KTT |
| Jan 17, 2002 | K014194 | MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. | KTT |
| Nov 20, 2001 | K013540 | EBI XFIX ACCESS PELVIC FIXATOR Ebi, L.P. | KTT |
| Nov 16, 2001 | K013503 | MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR DePuy Orthopaedics, Inc. | KTT |
| Nov 8, 2001 | K013378 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Sep 27, 2001 | K012078 | RADIOFIX Fixano SA | KTT |
| Sep 27, 2001 | K012062 | PF2 Fixano SA | KTT |
| Aug 15, 2001 | K011603 | VHS PEDIATRIC HIP SCREW SYSTEM Walter Abendschein, M.D. | KTT |
| Jul 25, 2001 | K012024 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Jun 29, 2001 | K011711 | MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM Ebi, L.P. | KTT |
| Jun 27, 2001 | K011697 | EBI XFIX ACCESS PELVIC FIXATOR Ebi, L.P. | KTT |
| Jun 27, 2001 | K011034 | SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM Synthes (Usa) | KTT |
| Jun 12, 2001 | K010766 | SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE Synthes (Usa) | KTT |
| May 23, 2001 | K010518 | SYNTHES ANTEROLATERAL CALCANEAL PLATE Synthes (Usa) | KTT |
| May 3, 2001 | K010344 | ADJUSTABLE LARGE FIXATOR SYSTEM Synthes (Usa) | KTT |
| Mar 13, 2001 | K010437 | MODIFICATION TO EBI XFIX DFS RAIL SYSTEM Ebi, L.P. | KTT |
| Jan 29, 2001 | K003397 | COLLES C SERIES FRAME STERILE PACK DePuy Orthopaedics, Inc. | KTT |
| May 23, 2000 | K001358 | EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM Ebi, L.P. | KTT |
| May 5, 2000 | K000734 | PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 Pioneer Surgical Technology | KTT |
| May 1, 2000 | K000682 | SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM Synthes (Usa) | KTT |
| Apr 28, 2000 | K000684 | SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM Synthes (Usa) | KTT |
| Feb 25, 2000 | K000319 | EBI XFIX DFS SYSTEM Ebi, L.P. | KTT |
| Feb 3, 2000 | K000083 | EBI XFIX DFS RAIL SYSTEM Ebi, L.P. | KTT |
| Jan 3, 2000 | K993873 | ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD Alphatec Mfg., Inc. | KTT |
| Dec 20, 1999 | K993289 | SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM Smith & Nephew, Inc. | KTT |
| Dec 14, 1999 | K993886 | EBI XFIX VISION FIXATION SYSTEM Ebi, L.P. | KTT |
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