510(k) K171964
K171964 is an FDA 510(k) premarket notification submitted by Mortise Medical, LLC for the device "LigaMetrics Suture Anchors". The FDA issued a decision of Substantially Equivalent on Sep 19, 2017. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Mortise Medical, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 19, 2017
- Date Received
- Jun 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)