Clearance Summary
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) received FDA 510(k) clearance under submission number K012095, 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 2001-07-26.
- Submission: K012095
- Applicant / Sponsor: Implex Corp.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2001-07-26
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.