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510(k) K130050

TITAN REVERSE SHOULDER SYSTEM by Ascension Orthopedic — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2013
Date Received
January 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Other clearances by Ascension Orthopedic

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  • K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (April 9, 2012)
  • K112278 — ASCENSION NUGRIP CMC IMPLANT (November 4, 2011)
  • K111799 — NUGAIT(TM) SUBTALAR IMPLANT SYSTEM (August 19, 2011)

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