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510(k) K151064

Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System by Biomet Spine — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 12, 2015
Date Received: April 20, 2015
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 Biomet Spine

K152622 — Alta ACDF System (July 8, 2016)
K153695 — Biomet Spine Fusion System (January 21, 2016)
K151974 — Polaris Spinal System (November 13, 2015)
K151483 — Biomet Spine Fusion System (July 31, 2015)
K151224 — Lineum OCT Spine System (June 30, 2015)
K142634 — Biomet Spine Fusion System (March 12, 2015)
K141791 — BIOMET FUSION SYSTEM (October 9, 2014)
K141804 — POLARIS SPINAL SYSTEM - HA COATED (September 25, 2014)
K121130 — POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS (June 15, 2012)
K112014 — ZYSTON STRAIGHT SPACER SYSTEM (October 17, 2011)

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)