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GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL

K043233 Class II Traditional
Decision Date
2005-02-01
Sponsor / Applicant
Efratgo, Ltd. HI Tech Bio-Surgical

Technical Specification

510(k) Submission ID K043233
Product Code HSB
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3020
Decision Date 2005-02-01
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL received FDA 510(k) clearance under submission number K043233, 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 2005-02-01.

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.