Panels › Orthopedic › Product code KWQ · Class 2
Appliance, Fixation, Spinal Intervertebral Body
Regulation 888.3060
11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 61MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 58MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 55MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 52MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 49MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 46MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 43MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 40MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.0 x 37MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.0 x 34MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.0 x 31MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.0 x 28MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.0 x 25MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.0 x 22MM, spinal implant component Terminated |
KWQ | None listed |
| Aug 20, 2009 | Stryker Spine Stryker Reflex Hybrid Variable Self-Tapping Screw.
Non Sterile. Manufactured by Stryker Spine, SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ 07430. Terminated |
KWQ | K040261 |
| Aug 20, 2009 | Stryker Spine Stryker Reflex Hybrid variable self-drilling screw.
Non Sterile.
Manufactured by Stryker Spine SAS, Cestas, France.
Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ 07430. Terminated |
KWQ | K040261 |
| Aug 20, 2009 | Stryker Spine Stryker Reflex Hybrid Level Anterior Cervical Plate;
Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430. Terminated |
KWQ | K040261 |
| Nov 20, 2008 | Stryker Spine Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile).
Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ.
The bone screw (R Terminated |
KWQ | K040261 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 88MM (Ti-6Al-4V); REF 600-04-188. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 84MM (Ti-6Al-4V); REF 600-04-184. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 80MM (Ti-6Al-4V); REF 600-04-180. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-176. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-172. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 68MM (Ti-6Al-4V); REF 600-04-168. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 64MM (Ti-6Al-4V); REF 600-04-164. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 60MM (Ti-6Al-4V); REF 600-04-160. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 66MM (Ti-6Al-4V); REF 600-03-166. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 63MM (Ti-6Al-4V); REF 600-03-163. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V); REF 600-03-160. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 57MM (Ti-6Al-4V); REF 600-03-157. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 54MM (Ti-6Al-4V); REF 600-03-154. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 51MM (Ti-6Al-4V); REF 600-03-151. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 48MM (Ti-6Al-4V); REF 600-03-148. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 45MM (Ti-6Al-4V); REF 600-03-145. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 44MM (Ti-6Al-4V); REF 600-02-144. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 42MM (Ti-6Al-4V); REF 600-02-142. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 40MM (Ti-6Al-4V); REF 600-02-140. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 38MM (Ti-6Al-4V); REF 600-02-138. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 36MM (Ti-6Al-4V); REF 600-02-136. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 34MM (Ti-6Al-4V); REF 600-02-134. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 32MM (Ti-6Al-4V); REF 600-02-132. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 30MM (Ti-6Al-4V); REF 600-02-130. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 28MM (Ti-6Al-4V); REF 600-01-128. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 26MM (Ti-6Al-4V); REF 600-01-126. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 24MM (Ti-6Al-4V); REF 600-01-124. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 22MM (Ti-6Al-4V); REF 600-01-122. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 20MM (Ti-6Al-4V); REF 600-01-120. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 18MM (Ti-6Al-4V); REF 600-01-118. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 16MM (Ti-6Al-4V); REF 600-01-116. Terminated |
KWQ | K031214 K040397 |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 14MM (Ti-6Al-4V); REF 600-01-114. Terminated |
KWQ | K031214 K040397 |
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