510(k) K110039
K110039 is an FDA 510(k) premarket notification submitted by Biomet Sports Medicine for the device "BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 3, 2011. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Biomet Sports Medicine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2011
- Date Received
- January 6, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type