Clearance Summary
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL received FDA 510(k) clearance under submission number K083648, sponsored by Efratgo, Ltd. HI Tech Bio-Surgical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-05-14.
- Submission: K083648
- Applicant / Sponsor: Efratgo, Ltd. HI Tech Bio-Surgical
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2009-05-14
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.