Clearance Summary
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 received FDA 510(k) clearance under submission number K021967, sponsored by Implex 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 2002-07-17.
- Submission: K021967
- Applicant / Sponsor: Implex Corp.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2002-07-17
Classification & Regulation
This clearance is catalogued under FDA product code MQP and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.