510(k) K170146
K170146 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "Galaxy UNYCO System". The FDA issued a decision of Substantially Equivalent on Oct 12, 2017. 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. Orthofix Srl has 97 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 12, 2017
- Date Received
- Jan 17, 2017
- 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)