510(k) K113796

SOLITAIRE-C CERVICAL SPACER SYSTEM by Ebi, LLC — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 26, 2012
Date Received: December 23, 2011
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 Ebi, LLC

K190837 — Internal Hex Implant System (January 22, 2020)
K170031 — Internal Octa Implant System (August 31, 2017)
K142426 — EBI External Implant System (March 27, 2015)
K140734 — NEXTGEN ALTIUS OCT SYSTEM (December 15, 2014)
K140123 — POLARIS SPINAL SYSTEM -TRANSLATION SCREW (April 24, 2014)
K111376 — CONSTRUX EXTERNAL FIXATION DEVICE (August 3, 2011)
K073116 — EBI INTERNAL IMPLANT SYSTEM (February 28, 2008)

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)