Clearance Summary
EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM received FDA 510(k) clearance under submission number K050766, sponsored by Zimmer Trabecular. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-05-26.
- Submission: K050766
- Applicant / Sponsor: Zimmer Trabecular
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 2005-05-26
Classification & Regulation
This clearance is catalogued under FDA product code HWE and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.