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510(k) K053119

DISTAL RADIO-ULNAR JOINT IMPLANT by Aptis Medical, LLC — Product Code KXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2005
Date Received
November 7, 2005
Clearance Type
Special
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

Other clearances by Aptis Medical, LLC

  • K190599 — Aptis Medical Distal Radio Ulnar Joint Implant (May 3, 2019)
  • K142569 — Aptis Medical Distal Radio Ulnar Joint Implant (April 3, 2015)
  • K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT (October 24, 2008)
  • K040497 — DISTAL RADIO-ULNAR JOINT IMPLANT (January 26, 2005)

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)
  • K052137 — ASCENSION MUH (November 3, 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)