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 |
|---|---|---|---|
| Jan 14, 1997 | K964275 | ALPHA POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Dec 9, 1996 | K962314 | HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM Osteonics Corp. | KWP |
| Dec 5, 1996 | K961633 | CD HORIZON SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Nov 27, 1996 | K962984 | ISOLA PEDIATRIC COMPONENTS Acromed Corp. | KWP |
| Nov 14, 1996 | K963639 | ACROMED PEDICLE SCREW Acromed Corp. | KWP |
| Oct 1, 1996 | K955807 | COTREL-DUBOUSSET (CD) SPINAL Sofamor Danek USA,Inc. | KWP |
| Mar 27, 1996 | K955365 | COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Mar 15, 1996 | K955864 | J.B. S. C1-C2 CLAMP J.B.S., S.A. | KWP |
| Mar 13, 1996 | K955927 | BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) Arcan Orthopaedic Corp. | KWP |
| Mar 11, 1996 | K954696 | ROGOZINSKI THORACOLUMBAR SPINAL ROD Smith & Nephew Richards, Inc. | KWP |
| Feb 16, 1996 | K955348 | TITANIUM MOSS MIAMI SPINAL SYSTEM Depuy, Inc. | KWP |
| Feb 14, 1996 | K951846 | MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS Alphatec Mfg., Inc. | KWP |
| Feb 9, 1996 | K955173 | SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc. | KWP |
| Feb 9, 1996 | K951164 | CD LIBERTY POSTERIOR SPINCAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Jan 25, 1996 | K954770 | CENTRA-LINE GRAPPLE, VARIFIX SYSTEM Advanced Spine Fixation Systems, Inc. | KWP |
| Jan 16, 1996 | K954645 | TITANIUM GDLH POSTERIOR SPINAL SYSTEM Sofamor Danek USA,Inc. | KWP |
| Dec 19, 1995 | K953599 | CLAMP ASSEMBLY J.B.S., S.A. | KWP |
| Dec 19, 1995 | K936294 | SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS Sofamor Danek Mfg., Inc. | KWP |
| Jul 11, 1995 | K942432 | J.B.S. CERVICAL SPINE SYSTEM J.B.S., S.A. | KWP |
| Jun 22, 1995 | K945781 | WEBB-MORLEY SPINE SYSTEM Electro-Biology, Inc. | KWP |
| May 31, 1995 | K945435 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) Arcan Orthopaedic Corp. | KWP |
| May 15, 1995 | K945022 | APOFIX CERVICAL SPINE FIXATION Sofamor Co., FR | KWP |
| Feb 1, 1995 | K931381 | AME UNIVERSAL FIXATION SYSTEM American Medical Electronics, Inc. | KWP |
| Oct 19, 1994 | K935113 | J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE J.B.S., S.A. | KWP |
| Sep 1, 1994 | K930009 | STRYKER 2S SPINAL SYSTEM Stryker Corp. | KWP |
| Jul 12, 1994 | K933881 | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM Depuy, Inc. | KWP |
| Jun 29, 1994 | K930657 | D-C-S SYSTEM Pina-Vertriebs, CH | KWP |
| Jun 29, 1994 | K930515 | ALPHA SPINAL SYSTEM Alphatec Mfg., Inc. | KWP |
| Jun 21, 1994 | K934582 | GDLH VARIABLE ANGLE CONNECTOR Danek Group, Inc. | KWP |
| Jun 3, 1994 | K934860 | TI-FRAME Johnson & Johnson Professionals, Inc. | KWP |
| Jun 2, 1994 | K934007 | SOFAMOR ORFIL SPINE FIXATION SYSTEM Sofamor Co., FR | KWP |
| May 4, 1994 | K933205 | TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON Danek Medical, Inc. | KWP |
| May 2, 1994 | K931225 | LOW PROFILE MID CROSS BRACING Advanced Spine Fixation Systems, Inc. | KWP |
| Apr 29, 1994 | K930891 | SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST Synthes (Usa) | KWP |
| Mar 28, 1994 | K931208 | LOW PROFILE SLEAVE NUT ASSEMBLY Advanced Spine Fixation Systems, Inc. | KWP |
| Mar 28, 1994 | K914548 | BRYAN SPINAL FIXATER (BSF) Arcan Orthopaedic Corp. | KWP |
| Feb 1, 1994 | K930531 | AME(R) RIGID FIXATION SYSTEM American Medical Electronics, Inc. | KWP |
| Oct 1, 1993 | K930710 | SENTRY POSTERIOR SPINAL SYSTEM Sofamor Danek Mfg., Inc. | KWP |
| Sep 21, 1993 | K924474 | SELBY INSTRUMENTATION Advanced Spine Fixation Systems, Inc. | KWP |
| Jun 24, 1993 | K921056 | COTREL - DUBOUSSET SPINE IMPLANTS Buckman Co., Inc. | KWP |
| Jun 22, 1993 | K921948 | SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST Synthes (Usa) | KWP |
| Jun 22, 1993 | K921767 | COMPACT COTREL -- DUBOUSSET SPINE SYSTEM Buckman Co., Inc. | KWP |
| Jun 15, 1993 | K924142 | CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT Codman & Shurtleff, Inc. | KWP |
| May 26, 1993 | K915672 | EDWARDS ADJUSTABLE CONNECTORS Scientific Spinal , Ltd. | KWP |
| May 18, 1993 | K925811 | TSRH CENTRAL POST HOOKS Sofamor Danek Mfg., Inc. | KWP |
| May 18, 1993 | K924381 | PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS Cross Medical Products, Inc. | KWP |
| May 18, 1993 | K922672 | AUGMENT POSTERIOR SPINAL FIXATION SYSTEM Sofamor Danek Mfg., Inc. | KWP |
| May 18, 1993 | K922504 | ISOLA(R) TANDEM CONNECTOR Acromed Corp. | KWP |
| May 18, 1993 | K921256 | LUQUE V SPINAL SYSTEM Sofamor Danek Mfg., Inc. | KWP |
| Jan 21, 1993 | K920546 | PARAGON POSTERIOR SPINAL SYSTEM Sofamor Danek Mfg., Inc. | KWP |
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