510(k) K162805
K162805 is an FDA 510(k) premarket notification submitted by Akros Medical for the device "Akros Fibulink Syndesmosis Repair Kit". The FDA issued a decision of Substantially Equivalent on Jan 10, 2017. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Akros Medical has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 10, 2017
- Date Received
- Oct 5, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)