Clearance Summary
NEXFLEX TOTAL HIP SYSTEM received FDA 510(k) clearance under submission number K042252, sponsored by Alphatec/Nexmed. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-12-06.
- Submission: K042252
- Applicant / Sponsor: Alphatec/Nexmed
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2004-12-06
Classification & Regulation
This clearance is catalogued under FDA product code LPH and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.