Panels › Orthopedic › Product code KWP · Class 2
Appliance, Fixation, Spinal Interlaminal
Regulation 888.3050
0510(k)s in 12 months (430 all time)
0recalls in 12 months (68 all time)
65recalls that name a 510(k)
Top companies in KWP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 54 | 12 |
| Synthes (Usa) | 17 | 0 |
| Zimmer, Inc. | 7 | 10 |
| Danek Medical, Inc. | 16 | 0 |
| K2m | 12 | 3 |
| Acromed Corp. | 14 | 0 |
| Seaspine, Inc. | 3 | 10 |
| Sofamor Danek USA,Inc. | 13 | 0 |
| Depuy, Inc. | 11 | 0 |
| Alphatec Spine, Inc. | 4 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 1988 | K882070 | LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS Karlin Technology, Inc. | KWP |
| Jun 3, 1988 | K882068 | COBB SPINAL ELEVATORS Karlin Technology, Inc. | KWP |
| Mar 4, 1988 | K880212 | TSRH H/M HOOK HOLDER W/ROD MOVER Warsaw Orthopedic, Inc. | KWP |
| Mar 4, 1988 | K880211 | TSRH H/M HOOK HOLDER Warsaw Orthopedic, Inc. | KWP |
| Mar 4, 1988 | K875290 | LUMBAR IMPACTION SET T. Korossurgical Instruments Corp. | KWP |
| Feb 18, 1988 | K880215 | TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD Warsaw Orthopedic, Inc. | KWP |
| Feb 18, 1988 | K880214 | TSRH H/M TORQUE LIMITING WRENCH Warsaw Orthopedic, Inc. | KWP |
| Feb 18, 1988 | K874882 | ACROMED CROSS ROD CONNECTOR Acromed Corp. | KWP |
| Jul 21, 1987 | K871870 | HSC UNIT ROD Research Development Corp., CA | KWP |
| Jun 30, 1987 | K870085 | ANTERIOR SPINAL FIXATION PLATE Terray Manufacturing, Inc., CA | KWP |
| May 4, 1987 | K870830 | WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM Warsaw Orthopedic, Inc. | KWP |
| Feb 11, 1986 | K854770 | MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM Advanced Biosearch Assn. | KWP |
| Dec 9, 1985 | K854524 | KIRSCHNER SPINAL PRODUCT SYSTEM Kirschner Medical Corp. | KWP |
| Nov 15, 1985 | K854313 | SONGER TITANIUM SPINE-L-ROD Ortho-Engineering Products Co. | KWP |
| Jun 7, 1985 | K851935 | EDWARDS SACRAL SCREW Zimmer, Inc. | KWP |
| May 29, 1985 | K850039 | HALIFAX SPINAL CLAMP Levtech, Inc. | KWP |
| Feb 13, 1985 | K843445 | SACRAL BAR Stuart | KWP |
| Jan 10, 1985 | K843687 | ROD FOR RACHIS SURGERY Sofamor Co. | KWP |
| Mar 23, 1984 | K840423 | HARRINGTON-TYPE INSTRU-SCOLIOSIS Link America, Inc. | KWP |
| Mar 19, 1982 | K820660 | A HOOK DRIVER Twin City Surgical, Inc. | KWP |
| Apr 8, 1981 | K810329 | DEPUY SEGMENTALSPINAL SYSTEM Depuy, Inc. | KWP |
| Feb 10, 1981 | K810224 | ARMSTRONG SPINAL APPLIANCE Howmedica Corp. | KWP |
| Dec 16, 1980 | K802462 | SYNTHES SPINAL IMPLANT SYSTEM Synthes (Usa) | KWP |
| May 20, 1980 | K801120 | DUNN ANTERIOR DISTRACTION SYSTEM Zimmer, Inc. | KWP |
| May 20, 1980 | K801080 | EDWARDS ROD SLEEVES Zimmer, Inc. | KWP |
| Jun 11, 1979 | K791009 | SANTA CASA DISTRACTOR Depuy, Inc. | KWP |
| Apr 12, 1979 | K790465 | KNEE COMPRESSION HOOK SYSTEM Zimmer, Inc. | KWP |
| Feb 12, 1979 | K790238 | TRANSVERSE TRACTION ASSEMBLY Zimmer, Inc. | KWP |
| Sep 27, 1978 | K781444 | OUTRIGGER DISTRACTION UNIT Orthopedic Equipment Co., Inc. | KWP |
| Sep 27, 1978 | K781443 | HARRINGTON SPINE INSTRUMENTATION Orthopedic Equipment Co., Inc. | KWP |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.