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FDA 510(k)

MAALEABLE FACIAL IMPLANT

K-Number: K915445 · 1992-02-03

ApplicantBiomet Ussc Orthopedics
Decision Date1992-02-03
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAALEABLE FACIAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Ussc Orthopedics. It received FDA 510(k) clearance on 1992-02-03 under 510(k) number K915445. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAALEABLE FACIAL IMPLANT?

MAALEABLE FACIAL IMPLANT is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is Biomet Ussc Orthopedics. The 510(k) number is K915445.

When did MAALEABLE FACIAL IMPLANT receive FDA 510(k) clearance?

MAALEABLE FACIAL IMPLANT received FDA 510(k) clearance on 1992-02-03, under 510(k) number K915445.

Who is the listed applicant for MAALEABLE FACIAL IMPLANT?

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

What is the FDA product code for MAALEABLE FACIAL IMPLANT?

The FDA product code for MAALEABLE FACIAL IMPLANT is KKY.

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Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USAK111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

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

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