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FDA 510(k)

PEEK-OPTIMA ALIF SPACER

K-Number: K081636 · 2008-08-07

ApplicantBiomet Spine
Decision Date2008-08-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK-OPTIMA ALIF SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine. It received FDA 510(k) clearance on 2008-08-07 under 510(k) number K081636. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEK-OPTIMA ALIF SPACER?

PEEK-OPTIMA ALIF SPACER is a medical device that received FDA 510(k) clearance on 2008-08-07. The listed applicant is Biomet Spine. The 510(k) number is K081636.

When did PEEK-OPTIMA ALIF SPACER receive FDA 510(k) clearance?

PEEK-OPTIMA ALIF SPACER received FDA 510(k) clearance on 2008-08-07, under 510(k) number K081636.

Who is the listed applicant for PEEK-OPTIMA ALIF SPACER?

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 PEEK-OPTIMA ALIF SPACER?

The FDA product code for PEEK-OPTIMA ALIF SPACER is MAX.

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Other records listing Biomet Spine as applicant

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.

K152622Alta ACDF SystemK121130POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODSK112014ZYSTON STRAIGHT SPACER SYSTEMK103393POLARIS SPINAL SYSTEMK093629SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEMK0910675.5 POLARIS SPINAL SYSTEM

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Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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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