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510(k) K143721

PRCT2 by Fx Solutions — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2015
Date Received
December 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K123814 — HUMELOCK II CEMENTED SHOULDER SYSTEM (August 13, 2013)
  • K111097 — HUMELOCK CEMENTED SHOULDER PROSTHESIS (November 9, 2011)

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