510(k) K171640
K171640 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "M-ARS ACL: Anatomic Ribbon Surgery System". The FDA issued a decision of Substantially Equivalent on Oct 23, 2017. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Medacta International S.A. has 207 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2017
- Date Received
- Jun 2, 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)