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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2009 | EBI, L.P. Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar;
Biomet Spine, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fract Terminated |
KWP | K993956 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immob Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immob Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immob Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | K051942 |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | K051942 |
| Aug 14, 2009 | DePuy Spine, Inc. DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300.
Intended to provide immobilization and stabilization of spinal segments in skeletally mature patien Terminated |
KWP | K070300 |
| Feb 7, 2008 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138. Terminated |
KWP | K991031 |
| Dec 13, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131 Terminated |
KWP | K052144 |
| Nov 16, 2006 | Zimmer Spine, Inc. Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Gui Terminated |
KWP | K022374 K041925 |
| Jul 20, 2004 | Spinal Concepts, Inc 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas Terminated |
KWP | K983258 |
| Jul 20, 2004 | Spinal Concepts, Inc 955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts, Austin, Texas Terminated |
KWP | K983260 |
| Jul 20, 2004 | Spinal Concepts, Inc 955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas Terminated |
KWP | K964404 |
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