510(k) K140625
K140625 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "ORTHOSORB LS". The FDA issued a decision of Substantially Equivalent on April 18, 2014. The device falls under product code OVZ (Pin, Fixation, Resorbable, Hard Tissue), a Class II device regulated under 21 CFR 888.3040. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2014
- Date Received
- March 11, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Resorbable, Hard Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.