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 |
|---|---|---|---|
| Mar 13, 2008 | K080394 | BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM Blackstone Medical, Inc. | KWP |
| Feb 14, 2008 | K073420 | BLACKSTONE ASCENT MULTIAXIAL SCREWS Blackstone Medical, Inc. | KWP |
| Jan 24, 2008 | K073654 | BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR Blackstone Medical, Inc. | KWP |
| Dec 13, 2007 | K072866 | ISSYS LP SPINAL FIXATION SYSTEM Custom Spine, Inc. | KWP |
| Dec 11, 2007 | K071942 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Oct 24, 2007 | K072081 | ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM Alphatec Spine, Inc. | KWP |
| Oct 15, 2007 | K062447 | TRAVERSE OCT SPINAL FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Oct 5, 2007 | K072568 | MODIFICATION TO OASYS SYSTEM Stryker Spine | KWP |
| Sep 14, 2007 | K070742 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Aug 15, 2007 | K071633 | LANX DEFORMITY SYSTEM Lanx, LLC | KWP |
| Aug 8, 2007 | K070341 | LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM Ldr Spine USA | KWP |
| Aug 6, 2007 | K071377 | POLARIS BE RODS Biomet Spine | KWP |
| Jul 20, 2007 | K070966 | GSO GS1 SPINAL SYSTEM Gold Standard Orthopaedics, LLC | KWP |
| May 30, 2007 | K070638 | THEKEN ATOLL CERVICO-THORACIC SYSTEM Theken Spine, LLC | KWP |
| May 25, 2007 | K061943 | ANATOMICA POSTERIOR CERVICAL FIXATION SYSTEM Anatomica AB | KWP |
| Apr 10, 2007 | K070300 | EXPEDIUM SFX CROSS CONNECTOR SYSTEM Depuy Spine, Inc. | KWP |
| Jan 16, 2007 | K062181 | C-JAWS CERVICAL COMPRESSIVE MINI FRAME Medicrea Technologies | KWP |
| Dec 26, 2006 | K062785 | LTD POLYAXIAL FIXATION SYSTEM Us Spine | KWP |
| Dec 22, 2006 | K062513 | APEX SPINE SYSTEM Spinecraft, Inc. | KWP |
| Sep 8, 2006 | K061591 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Sep 6, 2006 | K053418 | SYNTHES OC FUSION SYSTEM Synthes Spine Co.Lp | KWP |
| Aug 11, 2006 | K061579 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | KWP |
| May 23, 2006 | K052404 | DENALI DEFORMITY SYSTEM K2m, LLC | KWP |
| Apr 18, 2006 | K060683 | ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM Endius, Inc. | KWP |
| Mar 10, 2006 | K060513 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X Sintea Biotech, Inc. | KWP |
| Feb 13, 2006 | K060081 | BASIS SPINAL SYSTEM Medtronic Sofamor Danek | KWP |
| Nov 10, 2005 | K052201 | SOLANAS POSTERIOR STABILIZATION SYSTEM Alphatec Spine, Inc. | KWP |
| Oct 21, 2005 | K052734 | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Sep 28, 2005 | K052131 | EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS Depuy Spine, Inc. | KWP |
| Sep 23, 2005 | K052402 | VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Sep 23, 2005 | K052376 | MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Sep 23, 2005 | K052123 | SYNTHES PANGEA SYSTEM Synthes (Usa) | KWP |
| Sep 14, 2005 | K052247 | NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX Abbott Spine, Inc. | KWP |
| Sep 8, 2005 | K052181 | MODIFICATION TO XIA SPINAL SYSTEM Stryker Spine | KWP |
| Sep 7, 2005 | K051716 | VERTEBRON PSS PEDICLE SCREW SYSTEM Vertebron, Inc. | KWP |
| Aug 23, 2005 | K052180 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM Medtronic Sofamor Danek | KWP |
| Aug 18, 2005 | K051973 | MODIFICATION TO: XIA STAINLESS STEEL SYSTEM Stryker Spine | KWP |
| Aug 17, 2005 | K052069 | PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES Globus Medical, Inc. | KWP |
| Jul 27, 2005 | K051942 | MALIBU SPINAL SYSTEM Seaspine, Inc. | KWP |
| Jul 21, 2005 | K050391 | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM Globus Medical, Inc. | KWP |
| Jun 22, 2005 | K050830 | ZODIAC SPINAL FIXATION SYSTEM Alphatec/Nexmed | KWP |
| Jun 14, 2005 | K050809 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | KWP |
| May 4, 2005 | K050484 | BASIS SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | KWP |
| Apr 11, 2005 | K043053 | MODIFICATION TO CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek | KWP |
| Feb 16, 2005 | K050189 | TECHTONIX SYSTEM Stryker Spine | KWP |
| Feb 10, 2005 | K050079 | CD HORIZON SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | KWP |
| Jan 14, 2005 | K043522 | ISSYS PEDICLE SCREW SYSTEM Custom Spine, Inc. | KWP |
| Jan 12, 2005 | K043473 | MODIFICATION TO XIA SPINAL SYSTEM Stryker Spine | KWP |
| Jan 10, 2005 | K042635 | DENALI SPINE SYSTEM K2m, LLC | KWP |
| Jan 7, 2005 | K043020 | GLAXY 3.2 SPINAL SYSTEM Medtronic Sofamor Danek | KWP |
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