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510(k) K220336

Mg-PSZ Ceramic Femoral Head by Theken Companies — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2022
Date Received
February 7, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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  • K161184 — iNSitu Total Hip System (October 14, 2016)

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