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510(k) K081395

SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM by Biomet Spine — Product Code OVD

K081395 is an FDA 510(k) premarket notification submitted by Biomet Spine for the device "SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 2008. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), a Class II device regulated under 21 CFR 888.3080. Biomet Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2008
Date Received
May 19, 2008
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)
  • 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)

Other clearances for product code OVD

  • K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lum (July 15, 2026)
  • K260810 — Anteralign LS coverplate (June 10, 2026)
  • K254202 — MectaLIF 3D Metal Anterior (May 5, 2026)
  • K253401 — SCRIPT™ Implant System (April 29, 2026)
  • K253559 — Ventana™ A Anterior Lumbar Interbody System (February 25, 2026)
  • K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
  • K251575 — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interb (September 3, 2025)
  • 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)

FDA data resources