Solitaire Peek-Optima Anterior Spinal System

Q: What is the product code of K081395?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K081395 · Biomet Spine

Substantially Equivalent

510(k) numberK081395

Submission

Device name: Solitaire Peek-Optima Anterior Spinal System
Applicant: Biomet Spine
Parsippany, NJ, US
Received: May 19, 2008
Decision date: June 25, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

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 510(k)s with product code OVD

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K262025	Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional	INNO Holdings Inc. DBA Innovasis	09/11/2026SE
K261408	SABER-XA SystemOVD · Traditional	Elevation Spine	08/03/2026SE
K261809	Interwedge® Standalone LateralOVD · Special	Foundation Surgical Group	07/31/2026SE
K261353	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional	Kyocera Medical Technologies, Inc.	07/15/2026SE
K260810	Anteralign LS coverplateOVD · Traditional	Tyber Medical, LLC	06/10/2026SE
K254202	MectaLIF 3D Metal AnteriorOVD · Traditional	Medacta International S.A.	05/05/2026SE
K253401	SCRIPT Implant SystemOVD · Traditional	Globus Medical, Inc.	04/29/2026SE
K253559	Ventana A Anterior Lumbar Interbody SystemOVD · Traditional	Spinal Elements, Inc.	02/25/2026SE
K251829	DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional	Degen Medical	12/08/2025SE
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional	Alphatec Spine	09/03/2025SE

More from Alphatec Spine

510(k)	Device	Decision
K152622	Alta ACDF SystemOVE · Traditional	07/08/2016SE
K153695	Biomet Spine Fusion SystemMAX · Special	01/21/2016SE
K151974	Polaris Spinal SystemNKB · Traditional	11/13/2015SE
K151064	Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…OVE · Traditional	08/12/2015SE
K151483	Biomet Spine Fusion SystemMAX · Traditional	07/31/2015SE
K151224	Lineum OCT Spine SystemNKG · Traditional	06/30/2015SE
K142634	Biomet Spine Fusion SystemMAX · Traditional	03/12/2015SE
K141791	Biomet Fusion SystemOVD · Traditional	10/09/2014SE
K141804	Polaris Spinal System - Ha CoatedNKB · Traditional	09/25/2014SE
K121130	Polaris Spinal System-Ballista Spinal RodsNKB · Special	06/15/2012SE

Questions and answers

When was Solitaire Peek-Optima Anterior Spinal System cleared by the FDA?

Solitaire Peek-Optima Anterior Spinal System (K081395) received a 510(k) decision of Substantially Equivalent on June 25, 2008, 37 days after the submission was received.

What is the product code of K081395?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.