Clearance Summary
SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL received FDA 510(k) clearance under submission number K123745, sponsored by Biomecanica Industria E Comerico DE Productos Orto. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-03-25.
- Submission: K123745
- Applicant / Sponsor: Biomecanica Industria E Comerico DE Productos Orto
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2013-03-25
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.