510(k) K040397 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, May 6, 2004 |
| Received | Feb 17, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040397
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 14MM (Ti-6Al-4V); REF 600-01-114. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 16MM (Ti-6Al-4V); REF 600-01-116. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 18MM (Ti-6Al-4V); REF 600-01-118. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 20MM (Ti-6Al-4V); REF 600-01-120. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 22MM (Ti-6Al-4V); REF 600-01-122. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 24MM (Ti-6Al-4V); REF 600-01-124. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 26MM (Ti-6Al-4V); REF 600-01-126. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 1 Level, 28MM (Ti-6Al-4V); REF 600-01-128. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 30MM (Ti-6Al-4V); REF 600-02-130. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 32MM (Ti-6Al-4V); REF 600-02-132. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 34MM (Ti-6Al-4V); REF 600-02-134. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 36MM (Ti-6Al-4V); REF 600-02-136. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 38MM (Ti-6Al-4V); REF 600-02-138. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 40MM (Ti-6Al-4V); REF 600-02-140. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 42MM (Ti-6Al-4V); REF 600-02-142. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 2 Level, 44MM (Ti-6Al-4V); REF 600-02-144. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 45MM (Ti-6Al-4V); REF 600-03-145. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 48MM (Ti-6Al-4V); REF 600-03-148. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 51MM (Ti-6Al-4V); REF 600-03-151. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 54MM (Ti-6Al-4V); REF 600-03-154. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 57MM (Ti-6Al-4V); REF 600-03-157. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V); REF 600-03-160. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 63MM (Ti-6Al-4V); REF 600-03-163. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 3 Level, 66MM (Ti-6Al-4V); REF 600-03-166. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 60MM (Ti-6Al-4V); REF 600-04-160. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 64MM (Ti-6Al-4V); REF 600-04-164. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 68MM (Ti-6Al-4V); REF 600-04-168. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-172. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-176. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 80MM (Ti-6Al-4V); REF 600-04-180. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 84MM (Ti-6Al-4V); REF 600-04-184. Terminated |
KWQ | None listed |
| Sep 1, 2008 | Zimmer Inc. Zimmer Spine Cyclone anterior cervical plate, 4 Level, 88MM (Ti-6Al-4V); REF 600-04-188. Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.