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FDA 510(k)

ZIMMER COLLAGEN REPAIR PATCH

K-Number: K053562 · 2006-06-23

ApplicantTissue Science Laboratories, Plc
Decision Date2006-06-23
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZIMMER COLLAGEN REPAIR PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Science Laboratories, Plc. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K053562. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIMMER COLLAGEN REPAIR PATCH?

ZIMMER COLLAGEN REPAIR PATCH is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Tissue Science Laboratories, Plc. The 510(k) number is K053562.

When did ZIMMER COLLAGEN REPAIR PATCH receive FDA 510(k) clearance?

ZIMMER COLLAGEN REPAIR PATCH received FDA 510(k) clearance on 2006-06-23, under 510(k) number K053562.

Who is the listed applicant for ZIMMER COLLAGEN REPAIR PATCH?

The FDA 510(k) record lists Tissue Science Laboratories, Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZIMMER COLLAGEN REPAIR PATCH?

The FDA product code for ZIMMER COLLAGEN REPAIR PATCH is FTM.

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Other records listing Tissue Science Laboratories, Plc 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.

K050355PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150K043366PERMACOL SURGICAL IMPLANTK021056PERMACOLK013625PERMACOLK992556PERMACOL

Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

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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