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510(k) K140071

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2014
Date Received
January 13, 2014
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)
  • K130759 — HUMELOCK II CEMENTLESS SHOULDER SYSTEM (November 9, 2013)
  • K123814 — HUMELOCK II CEMENTED SHOULDER SYSTEM (August 13, 2013)
  • K111097 — HUMELOCK CEMENTED SHOULDER PROSTHESIS (November 9, 2011)

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