meddevicedb.com FDA Device Reference

INTERPLANTA SP TOTAL HIP PROSTHESIS

K790488 Class II Traditional
Decision Date
1979-03-28
Sponsor / Applicant
Waldemar Link GmbH & Co. KG

Technical Specification

510(k) Submission ID K790488
Product Code JDI
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3350
Decision Date 1979-03-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

INTERPLANTA SP TOTAL HIP PROSTHESIS received FDA 510(k) clearance under submission number K790488, sponsored by Waldemar Link GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1979-03-28.

Classification & Regulation

This clearance is catalogued under FDA product code JDI and 21 CFR 888.3350, within the Orthopedic review panel as a Class II device.