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 |
|---|---|---|---|
| Jul 14, 1992 | K910483 | MONOTUBE EXTERNAL FIXATION SYSTEM Howmedica Corp. | KTT |
| Jun 19, 1992 | K920608 | AMERICA SYSTEM I. Klimov Co. | KTT |
| Jan 21, 1992 | K920024 | RIHARDS TITANIUM HALF PIN Smith & Nephew Richards, Inc. | KTT |
| Jan 16, 1992 | K914558 | TRAUMAFIX (TM) EXTERNAL FIXATOR Synthes (Usa) | KTT |
| Jan 16, 1992 | K910986 | HOFFMANN DYNAMIC WRIST FIXATOR Howmedica Corp. | KTT |
| Aug 14, 1991 | K912162 | INTRAMEDULLARY HIP SCREW, MODIFICATION Smith & Nephew Richards, Inc. | KTT |
| May 29, 1991 | K911021 | PLATE BLADE WITH CURSOR OF L'UNION Sport Service, Inc. | KTT |
| Apr 2, 1991 | K905514 | AUTOGENESIS(TM) AUTOMATOR Advanced Biosearch Assn. | KTT |
| Feb 21, 1991 | K904973 | EXTERNAL FIXATION Dynasplint Systems, Inc. | KTT |
| Dec 11, 1990 | K905352 | BLADE PLATE O'Tec Corp. | KTT |
| Dec 11, 1990 | K905346 | JEWETT HIP NAIL O'Tec Corp. | KTT |
| Dec 11, 1990 | K905342 | LAG SCREW O'Tec Corp. | KTT |
| Dec 11, 1990 | K905338 | SIDE PLATE O'Tec Corp. | KTT |
| Oct 4, 1990 | K901234 | KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE Kirschner Medical Corp. | KTT |
| Jul 30, 1990 | K903251 | JEWETT HIP NAIL Onyx Medical Corp. | KTT |
| Jul 30, 1990 | K903250 | BLADE PLATE Onyx Medical Corp. | KTT |
| Jul 30, 1990 | K903246 | SIDE PLATE Onyx Medical Corp. | KTT |
| Apr 23, 1990 | K901525 | K-CAPE ORTHOPEDIC WIRES AND PINS Westcon Orthopedics, Inc. | KTT |
| Apr 23, 1990 | K901272 | ORION BLADE PLATE FOR TIBIAL OSTEOTOMY Med-Tek Corp. | KTT |
| Apr 18, 1990 | K900584 | ALTA LAG SCREW AND COMPRESSION SCREW Howmedica Corp. | KTT |
| Apr 5, 1990 | K890989 | DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR Origin Medsystems, Inc. | KTT |
| Mar 13, 1990 | K895507 | LINK GIEBEL BLADE PLATE SYSTEM Link America, Inc. | KTT |
| Jan 4, 1990 | K895241 | INTRAMEDULLARY HIP SCREW Richards Medical Co., Inc. | KTT |
| Aug 28, 1989 | K891066 | DANEK WRIST FIXATOR Danek Medical, Inc. | KTT |
| Aug 3, 1989 | K893639 | GAMMA LOCKING NAIL Howmedica Corp. | KTT |
| Jun 13, 1989 | K890814 | DANEK RING FIXATOR (DRF) Danek Medical, Inc. | KTT |
| Sep 22, 1988 | K883715 | AXIAL COMPRESSION SCREW Straub Clinic and Hospital | KTT |
| Sep 22, 1988 | K882922 | TECHMEDICA MP SYSTEM Techmedica, Inc. | KTT |
| Oct 28, 1987 | K873459 | ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT Howmedica Corp. | KTT |
| Aug 17, 1987 | K872224 | MODIFIED TROCHANTER CABLE GRIP SYSTEM Howmedica Corp. | KTT |
| Jun 26, 1987 | K872223 | MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM Howmedica Corp. | KTT |
| Jun 3, 1987 | K871248 | KRONNER COLLES-FOREARM EXTERNAL FIXATION Kronner Medical | KTT |
| Jun 1, 1987 | K870786 | AXIAL COMPRESSION SCREW Straub Clinic and Hospital | KTT |
| May 22, 1987 | K871249 | KRONNER BI-PLANER TIBIA EXTERNAL FIXATION Kronner Medical | KTT |
| May 22, 1987 | K871247 | KRONNER UNIVERSAL FRAME EXTERNAL FIXATION Kronner Medical | KTT |
| Mar 19, 1987 | K870961 | RICHARDS EXTERNAL FIXATION SYSTEM Richards Medical Co., Inc. | KTT |
| Sep 15, 1986 | K863343 | SUPERFIXATION(TM) Orthopaedic Device Corp. | KTT |
| Jul 25, 1986 | K862311 | SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN Warsaw Orthopedic, Inc. | KTT |
| Apr 15, 1986 | K861178 | DEPUY COMPRESSION HIP SCREW SYSTEM Depuy, Inc. | KTT |
| Nov 19, 1985 | K854205 | KIRSCHNER COMPRESSION HIP SCREW SYSTEM Kirschner Medical Corp. | KTT |
| Jul 15, 1985 | K850443 | MEC ROD CONNECTOR Pfizer, Inc. | KTT |
| Jul 15, 1985 | K850413 | MEC HIP BOLT Pfizer, Inc. | KTT |
| Jul 15, 1985 | K850403 | MEC DISTAL FEMORAL BOLT Pfizer, Inc. | KTT |
| Jun 28, 1985 | K851919 | SUPRACONDYLAR BONE PLATE Warsaw Orthopedic, Inc. | KTT |
| Jun 21, 1985 | K844068 | TROCHANTER CABLE GRIP SYSTEM Howmedica Corp. | KTT |
| Oct 22, 1984 | K843449 | AUTODYNAMIC COMPRESSION HIP SCREW-PLATE Mecron Medical Products, Inc. | KTT |
| Sep 25, 1984 | K842695 | T.O.D. PLATE SYS STERILE Kirschner Medical Corp. | KTT |
| Sep 25, 1984 | K842681 | T.O.D. PLATE SYSTEM Kirschner Medical Corp. | KTT |
| Sep 21, 1984 | K842768 | ACE/FISHER EXTERNAL FIXATOR Buckman Co., Inc. | KTT |
| Mar 25, 1983 | K830196 | CORSTREN COMPRESSION TUBE & PLATE Zimmer, Inc. | KTT |
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