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510(k) K052137

ASCENSION MUH by Ascension Orthopedics, Inc. — Product Code KXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2005
Date Received
August 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Hemi-, Ulnar
Device Class
Class II
Regulation Number
888.3810
Review Panel
OR
Submission Type

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  • K162153 — Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System (July 14, 2017)
  • K160830 — Integra External Fixation System (July 6, 2016)
  • K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (December 23, 2015)
  • K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System (October 29, 2015)
  • K151459 — Integra Total Ankle Replacement System (August 31, 2015)
  • K142413 — TITAN Modular Total Shoulder System (November 14, 2014)
  • K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM (February 13, 2013)

Other clearances for product code KXE

  • K190599 — Aptis Medical Distal Radio Ulnar Joint Implant (May 3, 2019)
  • K142569 — Aptis Medical Distal Radio Ulnar Joint Implant (April 3, 2015)
  • K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (April 9, 2012)
  • K081025 — ISOELASTICU (November 21, 2008)
  • K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT (October 24, 2008)
  • K061146 — SBI ULNAR HEAD IMPLANT (July 19, 2006)
  • K053119 — DISTAL RADIO-ULNAR JOINT IMPLANT (December 7, 2005)
  • K040497 — DISTAL RADIO-ULNAR JOINT IMPLANT (January 26, 2005)
  • K042902 — HERBERT ULNAR HEAD PROSTHESIS SYSTEM (December 27, 2004)
  • K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (July 28, 2004)