The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Mtf Pre-sutured Tendon.
| Device ID | K181633 |
| 510k Number | K181633 |
| Device Name: | MTF Pre-Sutured Tendon |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 |
| Contact | Katrina Carroll |
| Correspondent | Katrina Carroll Musculoskeletal Clinical Reulatory Advisers, LLC 125 May Street Edison, NJ 08837 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-06-20 |
| Decision Date | 2019-03-15 |