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510(k) K112438

TITAN MODULAR TOTAL SHOULDER SYSTEM by Ascension Orthopedic — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2012
Date Received
August 24, 2011
Clearance Type
Special
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

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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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