The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Trellis Collagen Ribbon.
Device ID | K131143 |
510k Number | K131143 |
Device Name: | TRELLIS COLLAGEN RIBBON |
Classification | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Sarah Holtgrewe |
Correspondent | Sarah Holtgrewe WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | OWY |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-23 |
Decision Date | 2013-10-07 |
Summary: | summary |