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 |
|---|---|---|---|
| Dec 21, 2004 | K043229 | MODIFICATION TO ALTIUS OCT SYSTEM Interpore Cross Intl. | KWP |
| Dec 21, 2004 | K042789 | VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Dec 17, 2004 | K043355 | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X Sintea Biotech, Inc. | KWP |
| Oct 27, 2004 | K042673 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM Alphatec/Nexmed | KWP |
| Oct 8, 2004 | K042524 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Oct 7, 2004 | K042508 | SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. | KWP |
| Oct 7, 2004 | K042498 | VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Oct 7, 2004 | K042143 | EXCELLA-M SPINAL SYSTEM Innovasis, Inc. | KWP |
| Oct 1, 2004 | K042402 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Oct 1, 2004 | K041808 | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM Endius, Inc. | KWP |
| Sep 24, 2004 | K041925 | ST360 SPINAL FIXATION SYSTEM Zimmer Spine, Inc. | KWP |
| Sep 16, 2004 | K041592 | CORAL SPINAL SYSTEM Theken Surgical | KWP |
| Sep 15, 2004 | K041862 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | KWP |
| Jul 19, 2004 | K041119 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | KWP |
| Jul 1, 2004 | K041449 | SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT Interpore Cross Intl. | KWP |
| Jul 1, 2004 | K040096 | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM Spinal Concepts, Inc. | KWP |
| Jun 10, 2004 | K041282 | MODIFICATION TO TSRH SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Apr 14, 2004 | K033961 | ALTIUS OCT SYSTEM Interpore Cross Intl. | KWP |
| Mar 26, 2004 | K033090 | ICON POLYAXIAL PEDICLE SCREW SYSTEM Alphatec Mfg., Inc. | KWP |
| Mar 3, 2004 | K033980 | BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) Blackstone Medical, Inc. | KWP |
| Nov 14, 2003 | K032094 | PASSMED SPINAL SYSTEM Medicrea | KWP |
| Nov 14, 2003 | K031175 | CLICK'X MONOAXIAL SCREWS AND HOOKS Synthes (Usa) | KWP |
| Oct 10, 2003 | K031471 | ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 Ortho Tec, LLC | KWP |
| Sep 5, 2003 | K031772 | TI FENESTRATED PLATE Interpore Cross Intl. | KWP |
| Aug 20, 2003 | K023884 | MODIFICATION ORIA SPINAL SYSTEM Ortho Tec, LLC | KWP |
| Jul 17, 2003 | K031893 | XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM Howmedica Osteonics Corp. | KWP |
| Jun 24, 2003 | K031595 | U & I AMERICA SPINAL HOOK SYSTEM U&I Corp., America | KWP |
| Jun 24, 2003 | K030875 | MODIFICATION TO COLORADO 2 SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Jun 18, 2003 | K031452 | ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 Ortho Tec, LLC | KWP |
| Jun 13, 2003 | K031533 | VANTAGE ANTERIOR FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Jun 12, 2003 | K030197 | BLACKSTONE POSTERIOR CERVICAL SYSTEM Blackstone Medical, Inc. | KWP |
| Jun 6, 2003 | K030816 | MSD CABLE REDUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Apr 24, 2003 | K031090 | MODIFICATION TO XIA STAINLESS STEEL SYSTEM Howmedica Osteonics Corp. | KWP |
| Feb 21, 2003 | K030253 | ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 Ortho Tec, LLC | KWP |
| Feb 21, 2003 | K030252 | ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) Ortho Tec, LLC | KWP |
| Feb 21, 2003 | K030241 | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | KWP |
| Jan 23, 2003 | K023804 | MOSS MIAMI SPINAL SYSTEM PIN NUT Depuyacromed | KWP |
| Dec 13, 2002 | K023797 | LAURAIN DEWALD ANTERIOR FIXATION SYSTEM Medtronic Sofamor Danek | KWP |
| Dec 13, 2002 | K023415 | MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM Medtronic Sofamor Danek | KWP |
| Dec 10, 2002 | K014296 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | KWP |
| Dec 4, 2002 | K022048 | INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM Interpore Cross Intl. | KWP |
| Nov 26, 2002 | K023675 | SYNTHES CERVIFIX/ AXON Synthes (Usa) | KWP |
| Nov 22, 2002 | K023555 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Nov 19, 2002 | K021679 | ORIA SPINAL CLIP SYSTEM Ortho Tec, LLC | KWP |
| Nov 13, 2002 | K023498 | MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM Blackstone Medical, Inc. | KWP |
| Sep 24, 2002 | K022374 | CADENCE SPINAL FIXATION SYSTEM Sulzer Spine-Tech | KWP |
| Aug 28, 2002 | K022191 | MODIFICATION TO TENOR SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Aug 27, 2002 | K022623 | 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) Depuyacromed | KWP |
| Aug 1, 2002 | K021507 | PLUS PIVOT LINK UNIVERSAL SYSTEM Spine Vision, Inc. | KWP |
| Jul 25, 2002 | K021061 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | KWP |
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