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 |
|---|---|---|---|
| Apr 24, 2000 | K001105 | MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS Depuyacromed | KWP |
| Dec 21, 1999 | K994187 | SYNTHES CERVIFIX SYSTEM Synthes (Usa) | KWP |
| Nov 19, 1999 | K992885 | VERSALOK LOW BACK FIXATION SYSTEM Osteotech, Inc. | KWP |
| Nov 16, 1999 | K993067 | SILHOUETTE SPINAL FIXATION SYSTEM Sulzer Spine-Tech | KWP |
| Nov 8, 1999 | K991662 | TITANIUM HARTSHILL SYSTEM Surgicraft , Ltd., GB | KWP |
| Oct 14, 1999 | K990986 | CONTOUR SPINAL SYSTEM Ortho Development Corp. | KWP |
| Aug 27, 1999 | K991198 | DYNA-LOK PLUS SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Aug 27, 1999 | K991089 | SYNTHES CERVIFIX SYSTEM Synthes Spine | KWP |
| Jul 23, 1999 | K991586 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc. | KWP |
| Jul 1, 1999 | K990965 | SYNTHES CERVIFIX SYSTEM Synthes (Usa) | KWP |
| Jun 2, 1999 | K990922 | OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR Howmedica Osteonics Corp. | KWP |
| Apr 30, 1999 | K984375 | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY Osteonics Corp. | KWP |
| Apr 29, 1999 | K990303 | EBI OMEGA 21 SYSTEM Electro-Biology, Inc. | KWP |
| Apr 13, 1999 | K990845 | MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 Advanced Spine Fixation Systems, Inc. | KWP |
| Mar 30, 1999 | K990708 | TITANIUM VERSALOK Wrightmedicaltechnologyinc | KWP |
| Jan 28, 1999 | K981676 | CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Jan 21, 1999 | K984377 | SYNTHES SPINE CERVIFIX SYSTEM Synthes (Usa) | KWP |
| Dec 22, 1998 | K983904 | ROGOZINSKI SPINAL ROD SYSTEM United States Surgical, A Division of Tyco Healthc | KWP |
| Dec 18, 1998 | K983353 | SCS SPINAL SYSTEM Orthotec, Inc. | KWP |
| Dec 16, 1998 | K983530 | SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM Synthes (Usa) | KWP |
| Dec 3, 1998 | K983583 | DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS Depuy, Inc. | KWP |
| Nov 25, 1998 | K982322 | SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM Synthes (Usa) | KWP |
| Nov 19, 1998 | K983282 | OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 Ohio Medical Instrument Co., Inc. | KWP |
| Nov 12, 1998 | K983706 | MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM Sofamor Danek USA,Inc. | KWP |
| Oct 26, 1998 | K983197 | SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) United States Surgical, A Division of Tyco Healthc | KWP |
| Oct 5, 1998 | K982490 | TENOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Sep 14, 1998 | K982511 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS Depuy, Inc. | KWP |
| Sep 14, 1998 | K982320 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM Depuy, Inc. | KWP |
| Sep 8, 1998 | K982494 | BWM SPINE SYSTEM Howmedica Corp. | KWP |
| Aug 28, 1998 | K982908 | MODIFICATION TO EBI SPINELINK SYSTEM Electro-Biology, Inc. | KWP |
| Aug 6, 1998 | K982011 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM DePuy Orthopaedics, Inc. | KWP |
| Jul 29, 1998 | K980288 | SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM Spine-Tech, Inc. | KWP |
| Jun 10, 1998 | K980121 | AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS Aesculap, Inc. | KWP |
| May 20, 1998 | K981452 | OSTEONICS LONG ARM CONTAINMENT RING Osteonics Corp. | KWP |
| May 11, 1998 | K980928 | SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM Synthes Spine | KWP |
| Apr 16, 1998 | K980358 | SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM Synthes (Usa) | KWP |
| Feb 18, 1998 | K974573 | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM Depuy, Inc. | KWP |
| Jan 8, 1998 | K973868 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc. | KWP |
| Oct 16, 1997 | K964159 | CD SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Aug 7, 1997 | K965221 | RANSFORD CERVICAL FIXATION SYSTEM Surgicraft , Ltd., GB | KWP |
| Jul 16, 1997 | K971457 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED Arcan Orthopaedic Corp. | KWP |
| Jun 18, 1997 | K971289 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc. | KWP |
| May 8, 1997 | K965224 | EMPOWER ANTERIOR DIRECT SCREWS Smith & Nephew Richards, Inc. | KWP |
| Apr 21, 1997 | K964254 | TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Mar 26, 1997 | K964404 | BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | KWP |
| Mar 26, 1997 | K964024 | DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM Depuy, Inc. | KWP |
| Mar 18, 1997 | K962628 | MOSS MIAMI SPINAL SYSTEM Depuy, Inc. | KWP |
| Mar 13, 1997 | K965145 | DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM Depuy, Inc. | KWP |
| Feb 6, 1997 | K962708 | TITANIUM CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Jan 24, 1997 | K960444 | FINN ROD TO ROD CONNECTOR Smith & Nephew Richards, Inc. | KWP |
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