510(k) K191483
K191483 is an FDA 510(k) premarket notification submitted by Medos International SARL for the device "HEALIX ADVANCE Anchor with DYNA+TAPE Sutures". The FDA issued a decision of Substantially Equivalent on Jun 28, 2019. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Medos International SARL has 95 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 28, 2019
- Date Received
- Jun 4, 2019
- Clearance Type
- Special
- 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)