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510(k) K123814

HUMELOCK II CEMENTED SHOULDER SYSTEM by Fx Solutions — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2013
Date Received
December 12, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
Review Panel
OR
Submission Type

Other clearances by Fx Solutions

  • K163669 — Humeris Shoulder (May 17, 2017)
  • K162455 — Humelock Reversed Shoulder (January 17, 2017)
  • K150488 — Humelock II Reversible Shoulder System (November 13, 2015)
  • K143721 — PRCT2 (August 27, 2015)
  • K140071 — HUMELOCK II CEMENTED SHOULDER SYSTEM (July 28, 2014)
  • K130759 — HUMELOCK II CEMENTLESS SHOULDER SYSTEM (November 9, 2013)
  • K111097 — HUMELOCK CEMENTED SHOULDER PROSTHESIS (November 9, 2011)

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