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BI-MENTUM™ ALTRX® Dual Mobility Liner

K203532 Class II Traditional
Decision Date
2021-04-28
Sponsor / Applicant
Depuy Ireland UC

Technical Specification

510(k) Submission ID K203532
Product Code LZO
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3353
Decision Date 2021-04-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

BI-MENTUM™ ALTRX® Dual Mobility Liner received FDA 510(k) clearance under submission number K203532, sponsored by Depuy Ireland UC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-04-28.

Classification & Regulation

This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.