The following data is part of a premarket notification filed by Musculoskeletal Transplant Foundation with the FDA for Mtf New Bone Void Filler.
| Device ID | K121313 |
| 510k Number | K121313 |
| Device Name: | MTF NEW BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET Edison, NJ 08837 |
| Contact | Nancy Joy |
| Correspondent | Nancy Joy 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 | 2012-05-02 |
| Decision Date | 2013-01-11 |
| Summary: | summary |