Clearance Summary
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM received FDA 510(k) clearance under submission number K123297, sponsored by Biomet Manufactuting Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-11-20.
- Submission: K123297
- Applicant / Sponsor: Biomet Manufactuting Corp.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3670
- Decision date: 2012-11-20
Classification & Regulation
This clearance is catalogued under FDA product code MBF and 21 CFR 888.3670, within the Orthopedic review panel as a Class II device.