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510(k) K231704

Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System by Life Spine, Inc. — Product Code OVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2023
Date Received
June 12, 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.

Other clearances by Life Spine, Inc.

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  • K250373 — ProLift Expandable Spacer System (April 9, 2025)
  • K243668 — ProLift Pivot Expandable Spacer System (January 23, 2025)
  • K243369 — Cervical Plating System (December 11, 2024)
  • K242826 — ProLift Wedge Expandable Spacer System (October 8, 2024)
  • K241464 — ARx® SAI Implant System (July 29, 2024)
  • K233455 — ARx MIS Spinal Screw System (December 12, 2023)
  • K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System (November 30, 2023)
  • K223430 — ProLift Micro Expandable Spacer System (May 4, 2023)

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)