510(k) K200196

Taperloc® Complete Hip Stems by Biomet Orthopedics — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2020
Date Received
January 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type