The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Collagen Ribbon.
| Device ID | K120019 |
| 510k Number | K120019 |
| Device Name: | COLLAGEN RIBBON |
| Classification | Mesh, Surgical |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Leslie Fitch |
| Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-02-23 |
| Summary: | summary |