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510(k) K223779

EMPOWR™ blade stem by Encore Medical, LLC — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2023
Date Received
December 16, 2022
Clearance Type
Traditional
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

Other clearances by Encore Medical, LLC

  • K052086 — ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER (August 31, 2005)

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