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FDA 510(k)

XENFORM SOFT TISSUE REPAIR MATRIX

K-Number: K060984 · 2006-05-17

ApplicantTei Biosciences, Inc.
Decision Date2006-05-17
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XENFORM SOFT TISSUE REPAIR MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2006-05-17 under 510(k) number K060984. 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 XENFORM SOFT TISSUE REPAIR MATRIX?

XENFORM SOFT TISSUE REPAIR MATRIX is a medical device that received FDA 510(k) clearance on 2006-05-17. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K060984.

When did XENFORM SOFT TISSUE REPAIR MATRIX receive FDA 510(k) clearance?

XENFORM SOFT TISSUE REPAIR MATRIX received FDA 510(k) clearance on 2006-05-17, under 510(k) number K060984.

Who is the listed applicant for XENFORM SOFT TISSUE REPAIR MATRIX?

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

What is the FDA product code for XENFORM SOFT TISSUE REPAIR MATRIX?

The FDA product code for XENFORM SOFT TISSUE REPAIR MATRIX is FTM.

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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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