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510(k) K213770

SP-CL Hip Stem and LCU Hip System by Waldemar Link GmbH & Co. KG — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2022
Date Received
December 2, 2021
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

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