510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142070Substantially Equivalent

Fortiva Porcine Dermis, Tutoplast Porcine Dermis

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Alachua FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142070 is the FDA 510(k) clearance record for FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS, a class II device, cleared for Rti Surgical, Inc. on under FDA product code FTM (Mesh, Surgical). FDA records list 100 510(k) clearances for RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), from to . As of , FDA records show no recalls naming K142070.

Clearance record

Decision date
Received
(89 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Rti Surgical, Inc. 11621 Research Cir., Alachua FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTM

Trailing 12 months
1 clearance under product code FTM in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260