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FDA 510(k)

FORTAFLEX SURGICAL MESH

K-Number: K020049 · 2002-03-18

ApplicantOrganogenesis, Inc.
Decision Date2002-03-18
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FORTAFLEX SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Organogenesis, Inc.. It received FDA 510(k) clearance on 2002-03-18 under 510(k) number K020049. 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 FORTAFLEX SURGICAL MESH?

FORTAFLEX SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2002-03-18. The listed applicant is Organogenesis, Inc.. The 510(k) number is K020049.

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

FORTAFLEX SURGICAL MESH received FDA 510(k) clearance on 2002-03-18, under 510(k) number K020049.

Who is the listed applicant for FORTAFLEX SURGICAL MESH?

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

What is the FDA product code for FORTAFLEX SURGICAL MESH?

The FDA product code for FORTAFLEX SURGICAL MESH is FTM.

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Other records listing Organogenesis, Inc. as applicant

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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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