Home / 510(k) Clearances / K221794

510(k) K221794

Vario-Cup System by Waldemar Link GmbH & Co. KG — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2022
Date Received
June 21, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

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