Atlas FDA

CYCLONE ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k) clearance K031214 · decided 2003-09-23

Clearance details

K-number
K031214
Device name
CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Encore Medical L.P.
Decision
Substantially Equivalent
Date received
2003-04-17
Decision date
2003-09-23
Days to decision
159 days
Clearance type
Traditional
Product code
KWQ
Device class
2
Regulation number
888.3060
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Austin, TX, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Palisades™ Buttress Plate System (K261309)Bethesda Medical Devices, LLC2026-07-16
ARIES Anterior Cervical Plate Systems (K252776)ZheJiang Decans Medical Devices Co., Ltd.2026-05-14
CastleLoc-P Anterior Cervical Plate System (K261112)L&K BIOMED Co., Ltd.2026-05-06
corra™ cervical plating system (K260570)Carlsmed, Inc.2026-04-22
VyPlate™ Anterior Cervical Plate System (K260697)Vy Spine, LLC2026-03-27
ANTERIS Thoracolumbar Plate System (K260015)SpineCraft2026-03-04
PathLoc Lumbar Plate System (K251940)L&K BIOMED Co., Ltd.2026-03-03
Aster (K254182)Osteonic Co., Ltd.2026-02-26
Lumbar Spine Truss System - Plating Solution (LSTS-PS) (K253201)4Web, Inc.2026-02-12
aprevo® cervical plating system (K252611)Carlsmed, Inc.2025-12-22
Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (K251965)Alphatec Spine, Inc.2025-08-28
Resolve Anterior Cervical Plate System (K251436)Pioneer Surgical Technology, Inc.2025-07-11

Recalls involving this device

RecordFirmDate
Zimmer Spine Cyclone anterior cervical plate, 1 Level, 14MM (Ti-6Al-4V); REF 600-01-114. recall (Z-1717-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 1 Level, 16MM (Ti-6Al-4V); REF 600-01-116. recall (Z-1718-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 1 Level, 18MM (Ti-6Al-4V); REF 600-01-118. recall (Z-1719-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 1 Level, 20MM (Ti-6Al-4V); REF 600-01-120. recall (Z-1720-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 1 Level, 22MM (Ti-6Al-4V); REF 600-01-122. recall (Z-1721-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 1 Level, 24MM (Ti-6Al-4V); REF 600-01-124. recall (Z-1722-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 1 Level, 26MM (Ti-6Al-4V); REF 600-01-126. recall (Z-1723-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 1 Level, 28MM (Ti-6Al-4V); REF 600-01-128. recall (Z-1724-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 2 Level, 30MM (Ti-6Al-4V); REF 600-02-130. recall (Z-1725-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 2 Level, 32MM (Ti-6Al-4V); REF 600-02-132. recall (Z-1726-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 2 Level, 34MM (Ti-6Al-4V); REF 600-02-134. recall (Z-1727-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 2 Level, 36MM (Ti-6Al-4V); REF 600-02-136. recall (Z-1728-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 2 Level, 38MM (Ti-6Al-4V); REF 600-02-138. recall (Z-1729-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 2 Level, 40MM (Ti-6Al-4V); REF 600-02-140. recall (Z-1730-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 2 Level, 42MM (Ti-6Al-4V); REF 600-02-142. recall (Z-1731-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 2 Level, 44MM (Ti-6Al-4V); REF 600-02-144. recall (Z-1732-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 45MM (Ti-6Al-4V); REF 600-03-145. recall (Z-1733-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 48MM (Ti-6Al-4V); REF 600-03-148. recall (Z-1734-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 51MM (Ti-6Al-4V); REF 600-03-151. recall (Z-1735-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 54MM (Ti-6Al-4V); REF 600-03-154. recall (Z-1736-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 57MM (Ti-6Al-4V); REF 600-03-157. recall (Z-1737-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 60MM (Ti-6Al-4V); REF 600-03-160. recall (Z-1738-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 63MM (Ti-6Al-4V); REF 600-03-163. recall (Z-1739-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 3 Level, 66MM (Ti-6Al-4V); REF 600-03-166. recall (Z-1740-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 4 Level, 60MM (Ti-6Al-4V); REF 600-04-160. recall (Z-1741-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 4 Level, 64MM (Ti-6Al-4V); REF 600-04-164. recall (Z-1742-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 4 Level, 68MM (Ti-6Al-4V); REF 600-04-168. recall (Z-1743-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-172. recall (Z-1744-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 4 Level, 72MM (Ti-6Al-4V); REF 600-04-176. recall (Z-1745-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 4 Level, 80MM (Ti-6Al-4V); REF 600-04-180. recall (Z-1746-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 4 Level, 84MM (Ti-6Al-4V); REF 600-04-184. recall (Z-1747-2008)Zimmer Inc.2008-09-01
Zimmer Spine Cyclone anterior cervical plate, 4 Level, 88MM (Ti-6Al-4V); REF 600-04-188. recall (Z-1748-2008)Zimmer Inc.2008-09-01