510(k) K150424
K150424 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "JuggerStitch Meniscal Repair Device". The FDA issued a decision of Substantially Equivalent on May 15, 2015. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2015
- Date Received
- February 19, 2015
- 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