The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Allofix Anchor.
| Device ID | K053339 |
| 510k Number | K053339 |
| Device Name: | ALLOFIX ANCHOR |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Contact | Nancy L Bennewitz |
| Correspondent | Nancy L Bennewitz MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Product Code | GAT |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDW |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-01 |
| Decision Date | 2006-03-16 |
| Summary: | summary |