Search Results
Found 1 results
510(k) Data Aggregation
K Number
K130547Device Name
ENDOFORM RECONSTRUCTIVE TEMPLATE
Manufacturer
MESYNTHE LTD
Date Cleared
2013-05-31
(88 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
MESYNTHE LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform™ Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the following procedures; hernioplasty and repair of body wall defects. The device allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.
Device Description
The Mesynthes Endoform™ Reconstructive Template (ERT) is a surgical mesh comprising either a single layer of decellularized extracellular matrix (ECM) or alternatively, multiple layers (2- to 10- layers) of ECM bonded together by dehydrothermal lamination and polyglycolic acid (PGA) suture material.
Ask a Question
Page 1 of 1