510(k) K221049

Zavation VariSync Plate System and VariSync Spacer System by Zavation Medical Products, LLC — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 12, 2022
Date Received: April 11, 2022
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 Medical Products, LLC

K243908 — Tiger 2 System (February 3, 2025)
K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, (April 10, 2024)
K231811 — Zavation Connector System (August 22, 2023)
K223808 — Zavation Navigation Instrument System (July 12, 2023)
K230731 — Zavation ALIF System (June 14, 2023)
K221726 — Uni-FuZe-C Bone Strip (January 18, 2023)
K222614 — Zavation Spinal System (December 5, 2022)
K220581 — Zavation eZspand Interbody System (June 2, 2022)
K212811 — Ti3Z Lumbar Interbody System (April 12, 2022)
K211993 — Z-LINKPC System (August 11, 2021)

Other clearances for product code OVE

K260038 — E3D-C Interbody System (February 4, 2026)
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)