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510(k) K141005

Z-LINK CERVICAL by Zavation, LLC — Product Code OVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2014
Date Received
April 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Zavation, LLC

  • K162206 — Zavation IBF (April 4, 2017)
  • K162575 — Z-LINKPC System (March 3, 2017)
  • K162824 — Z-Span Plate System (February 17, 2017)
  • K161016 — Z-Clamp ISP System (October 19, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160362 — Z-Span Plate System (March 22, 2016)
  • K142392 — Zavation Posterior LEIF (April 29, 2015)
  • K142271 — Zavation Z-Link Lumbar (December 19, 2014)
  • K141419 — ZVPLASTY (September 12, 2014)
  • K130030 — ZAVATION CERVICAL PLATE SYSTEM (April 25, 2013)

Other clearances for product code OVE

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  • K253876 — HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (December 22, 2025)
  • K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
  • K250076 — Endeavor™ Stand-Alone Cervical IBF System (September 25, 2025)
  • K250540 — SABER-C System (August 8, 2025)
  • K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
  • K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
  • K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
  • K242928 — Tesera-k SC System (April 10, 2025)
  • K243188 — CYLOX® ST (February 11, 2025)