510(k) K141791

BIOMET FUSION SYSTEM by Biomet Spine — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 9, 2014
Date Received: July 2, 2014
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar 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)
K151064 — Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge (August 12, 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)
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 OVD

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K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)