The following data is part of a premarket notification filed by Restore Surgical Llc Dba Instratek with the FDA for Toetac Hammertoe Fixation System.
| Device ID | K150443 |
| 510k Number | K150443 |
| Device Name: | ToeTac Hammertoe Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | RESTORE SURGICAL LLC Dba Instratek 15200 Middlebrook Drive, Suite G Houston, TX 77058 |
| Contact | Jeff Seavey |
| Correspondent | Jeff Seavey RESTORE SURGICAL LLC Dba Instratek 15200 Middlebrook Drive, Suite G Houston, TX 77058 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-20 |
| Decision Date | 2015-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327356366 | K150443 | 000 |
| 07613327356359 | K150443 | 000 |
| 07613327356304 | K150443 | 000 |