510(k) K160972
K160972 is an FDA 510(k) premarket notification submitted by Gexfix International Corp. for the device "Gexfix External Fixation". The FDA issued a decision of Substantially Equivalent on Dec 28, 2016. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 28, 2016
- Date Received
- Apr 6, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)