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FDA 510(k)

UHMWPE SURGICAL MESH

K-Number: K894478 · 1990-03-08

ApplicantBiomet, Inc.
Decision Date1990-03-08
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UHMWPE SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1990-03-08 under 510(k) number K894478. 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 UHMWPE SURGICAL MESH?

UHMWPE SURGICAL MESH is a medical device that received FDA 510(k) clearance on 1990-03-08. The listed applicant is Biomet, Inc.. The 510(k) number is K894478.

When did UHMWPE SURGICAL MESH receive FDA 510(k) clearance?

UHMWPE SURGICAL MESH received FDA 510(k) clearance on 1990-03-08, under 510(k) number K894478.

Who is the listed applicant for UHMWPE SURGICAL MESH?

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

What is the FDA product code for UHMWPE SURGICAL MESH?

The FDA product code for UHMWPE SURGICAL MESH is KKY.

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Other records listing Biomet, Inc. as applicant

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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

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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