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FDA 510(k)

FORTIVA PORCINE DERMIS

K-Number: K123356 · 2013-03-05

ApplicantRti Biologics, Inc.
Decision Date2013-03-05
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FORTIVA PORCINE DERMIS is the device name listed in this FDA 510(k) record. The listed applicant is Rti Biologics, Inc.. It received FDA 510(k) clearance on 2013-03-05 under 510(k) number K123356. 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 FORTIVA PORCINE DERMIS?

FORTIVA PORCINE DERMIS is a medical device that received FDA 510(k) clearance on 2013-03-05. The listed applicant is Rti Biologics, Inc.. The 510(k) number is K123356.

When did FORTIVA PORCINE DERMIS receive FDA 510(k) clearance?

FORTIVA PORCINE DERMIS received FDA 510(k) clearance on 2013-03-05, under 510(k) number K123356.

Who is the listed applicant for FORTIVA PORCINE DERMIS?

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

What is the FDA product code for FORTIVA PORCINE DERMIS?

The FDA product code for FORTIVA PORCINE DERMIS is FTM.

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Other records listing Rti Biologics, Inc. 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.

K091142TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358K081538TUTOPATCH, TUTOMESH

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.

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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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