510(k) K122437
K122437 is an FDA 510(k) premarket notification submitted by Biomet Sports Medicine for the device "NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS". The FDA issued a decision of Substantially Equivalent on October 18, 2013. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Biomet Sports Medicine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2013
- Date Received
- August 10, 2012
- 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