The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Mtf Allograft Anchor.
| Device ID | K042038 |
| 510k Number | K042038 |
| Device Name: | MTF ALLOGRAFT ANCHOR |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin MUSCULOSKELETAL TRANSPLANT FOUNDATION 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-07-29 |
| Decision Date | 2004-12-23 |
| Summary: | summary |