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510(k) K234119

UniSpace® Stand-Alone C Cage by Innosys Co., Ltd. — Product Code OVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2024
Date Received
December 28, 2023
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.

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  • 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)
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  • K243188 — CYLOX® ST (February 11, 2025)