The following data is part of a premarket notification filed by Metasurg with the FDA for Metasurg Subtalar Implant.
| Device ID | K070441 |
| 510k Number | K070441 |
| Device Name: | METASURG SUBTALAR IMPLANT |
| Classification | Screw, Fixation, Bone |
| Applicant | METASURG 16350 PARK TEN PL., SUITE 101 Houston, TX 77084 |
| Contact | Larry Weatherford |
| Correspondent | Larry Weatherford METASURG 16350 PARK TEN PL., SUITE 101 Houston, TX 77084 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-15 |
| Decision Date | 2007-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420128928 | K070441 | 000 |
| 00840420128911 | K070441 | 000 |
| 00840420128904 | K070441 | 000 |
| 00840420128898 | K070441 | 000 |
| 00840420128881 | K070441 | 000 |