Clearance Summary
THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) received FDA 510(k) clearance under submission number K021970, 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 2002-07-12.
- Submission: K021970
- Applicant / Sponsor: Implex Corp.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2002-07-12
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.