ToeTac™ 10° Hammertoe Fixation System
Screw, Fixation, Bone
RESTORE SURGICAL LLC DBA INSTRATEK
The following data is part of a premarket notification filed by Restore Surgical Llc Dba Instratek with the FDA for Toetac™ 10° Hammertoe Fixation System.
Pre-market Notification Details
| Device ID | K161778 |
| 510k Number | K161778 |
| Device Name: | ToeTac™ 10° Hammertoe Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | RESTORE SURGICAL LLC DBA INSTRATEK 15200 MIDDLEBROOK DR., SUITE G Houston, TX 77058 |
| Contact | Jeff Seavey |
| Correspondent | Jeff Seavey RESTORE SURGICAL LLC DBA INSTRATEK 15200 MIDDLEBROOK DR., 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 | 2016-06-29 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327356298 | K161778 | 000 |
| 07613327356229 | K161778 | 000 |
| 07613327356151 | K161778 | 000 |
Trademark Results [ToeTac]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOETAC 86511748 4942520 Live/Registered |
HOWMEDICA OSTEONICS CORP 2015-01-22 |
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