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FDA 510(k)

ORTHOMEND SOFT TISSUE MATRIX

K-Number: K071807 · 2007-08-06

ApplicantTei Biosciences, Inc.
Decision Date2007-08-06
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORTHOMEND SOFT TISSUE 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 2007-08-06 under 510(k) number K071807. 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 ORTHOMEND SOFT TISSUE MATRIX?

ORTHOMEND SOFT TISSUE MATRIX is a medical device that received FDA 510(k) clearance on 2007-08-06. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K071807.

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

ORTHOMEND SOFT TISSUE MATRIX received FDA 510(k) clearance on 2007-08-06, under 510(k) number K071807.

Who is the listed applicant for ORTHOMEND SOFT TISSUE 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 ORTHOMEND SOFT TISSUE MATRIX?

The FDA product code for ORTHOMEND SOFT TISSUE 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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