Fortiva Porcine Dermis

FDA 510(k) K123356 · Rti Biologics, Inc.

Substantially Equivalent

510(k) numberK123356

Submission

Device name
Fortiva Porcine Dermis
Applicant
Rti Biologics, Inc.
Alachua, FL, US
Received
October 31, 2012
Decision date
March 5, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FTM – Mesh, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was Fortiva Porcine Dermis cleared by the FDA?

Fortiva Porcine Dermis (K123356) received a 510(k) decision of Substantially Equivalent on March 5, 2013, 125 days after the submission was received.

What is the product code of K123356?

The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.