510(k) K172620
K172620 is an FDA 510(k) premarket notification submitted by Mortise Medical, LLC for the device "SyndesMetrics Syndesmosis Repair System". The FDA issued a decision of Substantially Equivalent on Nov 8, 2017. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Mortise Medical, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 2017
- Date Received
- Aug 31, 2017
- 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)