The following data is part of a premarket notification filed by Allosource with the FDA for Reconnex Pre-sutured Tendon.
| Device ID | K170957 |
| 510k Number | K170957 |
| Device Name: | ReConnex Pre-Sutured Tendon |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | AlloSource 6278 S Troy Circle Centennial, CO 80111 |
| Contact | Pamela Vetter |
| Correspondent | Trevor Wright AlloSource 6278 S Troy Circle Centennial, CO 80111 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2018-03-20 |
| Summary: | summary |