The following data is part of a premarket notification filed by Rti Surgical, Inc. with the FDA for Fortiva Porcine Dermis, Tutoplast Porcine Dermis.
| Device ID | K142070 |
| 510k Number | K142070 |
| Device Name: | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS |
| Classification | Mesh, Surgical |
| Applicant | RTI SURGICAL, INC. 11621 Research Cir Alachua, FL 32615 |
| Contact | Kristina Hall |
| Correspondent | Kristina Hall RTI SURGICAL, INC. 11621 Research Cir Alachua, FL 32615 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-30 |
| Decision Date | 2014-10-27 |
| Summary: | summary |