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FDA 510(k)

SOLITAIRE ANTERIOR SPINAL SYSTEM

K-Number: K081501 · 2008-07-02

ApplicantBiomet Spine
Decision Date2008-07-02
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOLITAIRE ANTERIOR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine. It received FDA 510(k) clearance on 2008-07-02 under 510(k) number K081501. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLITAIRE ANTERIOR SPINAL SYSTEM?

SOLITAIRE ANTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-02. The listed applicant is Biomet Spine. The 510(k) number is K081501.

When did SOLITAIRE ANTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

SOLITAIRE ANTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 2008-07-02, under 510(k) number K081501.

Who is the listed applicant for SOLITAIRE ANTERIOR SPINAL SYSTEM?

The FDA 510(k) record lists Biomet Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLITAIRE ANTERIOR SPINAL SYSTEM?

The FDA product code for SOLITAIRE ANTERIOR SPINAL SYSTEM is OVD.

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Other records listing Biomet Spine as applicant

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Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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