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510(k) K050657

MONDEAL CONTOUR HO SYSTEM by Kapp Surgical Instrument, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2005
Date Received
March 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Kapp Surgical Instrument, Inc.

  • K200289 — Michler-Kapp Cardiovascular Vent Catheter (January 28, 2021)
  • K072216 — KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 (November 9, 2007)
  • K050384 — KAPP BARI-RING, MODEL KS-BR-2005 (January 13, 2006)
  • K050655 — MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 (August 8, 2005)
  • K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (July 28, 2004)
  • 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)

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