510(k) K140908
K140908 is an FDA 510(k) premarket notification submitted by Biomet Sports Medicine for the device "JUGGERKNOT MINI SOFT ANCHOR". The FDA issued a decision of Substantially Equivalent on October 2, 2014. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Biomet Sports Medicine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2014
- Date Received
- April 9, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type