The following data is part of a premarket notification filed by Sanatmetal Mfr. Of Orthopaedic/traumatologic Prod. with the FDA for Sanatmetal Nails And Pins.
| Device ID | K070761 |
| 510k Number | K070761 |
| Device Name: | SANATMETAL NAILS AND PINS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD. 111 HILL ROAD Douglassville, PA 19518 |
| Contact | Donald Guthner |
| Correspondent | Donald Guthner SANATMETAL MFR. OF ORTHOPAEDIC/TRAUMATOLOGIC PROD. 111 HILL ROAD Douglassville, PA 19518 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-20 |
| Decision Date | 2008-02-07 |
| Summary: | summary |