The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Mec Intramedullary Rod.
| Device ID | K850441 |
| 510k Number | K850441 |
| Device Name: | MEC INTRAMEDULLARY ROD |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Contact | Barbara G Ramseyer |
| Correspondent | Barbara G Ramseyer PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-05 |
| Decision Date | 1985-04-19 |