510(k) K142070

FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS by Rti Surgical, Inc. — Product Code FTM

K142070 is an FDA 510(k) premarket notification submitted by Rti Surgical, Inc. for the device "FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS". The FDA issued a decision of Substantially Equivalent on October 27, 2014. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Rti Surgical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2014
Date Received
July 30, 2014
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type