The following data is part of a premarket notification filed by Rti Biologics, Inc. with the FDA for Fortiva Porcine Dermis.
| Device ID | K123356 |
| 510k Number | K123356 |
| Device Name: | FORTIVA PORCINE DERMIS |
| Classification | Mesh, Surgical |
| Applicant | RTI BIOLOGICS, INC. 11621 RESEARCH CIRCLE P.O. BOX 2650 Alachua, FL 32616 -1627 |
| Contact | Esther Carbon |
| Correspondent | Esther Carbon RTI BIOLOGICS, INC. 11621 RESEARCH CIRCLE P.O. BOX 2650 Alachua, FL 32616 -1627 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-03-05 |
| Summary: | summary |