510(k) K150443
K150443 is an FDA 510(k) premarket notification submitted by Restore Surgical, LLC Dba Instratek for the device "ToeTac Hammertoe Fixation System". The FDA issued a decision of Substantially Equivalent on Jun 4, 2015. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Restore Surgical, LLC Dba Instratek has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 4, 2015
- Date Received
- Feb 20, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)