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510(k) K033930

KAPP CUSTOM ULNAR HEAD WRIST IMPLANT by Kapp Surgical Instrument, Inc. — Product Code KXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2004
Date Received
December 18, 2003
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

Other clearances by Kapp Surgical Instrument, Inc.

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  • K072216 — KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 (November 9, 2007)
  • K050384 — KAPP BARI-RING, MODEL KS-BR-2005 (January 13, 2006)
  • K050657 — MONDEAL CONTOUR HO SYSTEM (August 8, 2005)
  • K050655 — MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 (August 8, 2005)
  • K030237 — KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT (August 29, 2003)
  • K844177 — COSGROVE MITRAL VALVE RETRACTOR (November 8, 1984)
  • K843368 — KAPP SPINAL BUTTON (September 12, 1984)

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)
  • K052137 — ASCENSION MUH (November 3, 2005)
  • K040497 — DISTAL RADIO-ULNAR JOINT IMPLANT (January 26, 2005)
  • K042902 — HERBERT ULNAR HEAD PROSTHESIS SYSTEM (December 27, 2004)