The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Aft.
| Device ID | K042125 |
| 510k Number | K042125 |
| Device Name: | AFT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Contact | Karen Hardwick |
| Correspondent | Karen Hardwick MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-06 |
| Decision Date | 2005-07-28 |
| Summary: | summary |