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510(k) K032806

KATALYST RADIAL HEAD IMPLANT by Kinetikos Medical, Inc. — Product Code KWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2004
Date Received
September 9, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Hemi-, Radial, Polymer
Device Class
Class II
Regulation Number
888.3170
Review Panel
OR
Submission Type

Other clearances by Kinetikos Medical, Inc.

  • K061749 — ECLIPSE TOTAL ANKLE IMPLANT (November 22, 2006)
  • K061465 — KMI CEMENT RESTRICTOR IMPLANT (October 5, 2006)
  • K051611 — MBARESORB IMPLANT (September 6, 2005)
  • K041461 — KMI DISTAL VOLAR RADIUS PLATE SYSTEM (August 16, 2004)
  • K040356 — KOMPRESSOR SCREW SYSTEM (March 1, 2004)
  • K024233 — KOMPRESSOR SCREW SYSTEM (February 6, 2003)
  • K030037 — UNIVERSAL TOTAL WRIST SYSTEM (February 5, 2003)
  • K023770 — K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) (December 12, 2002)
  • K020554 — MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM (May 3, 2002)
  • K991873 — KMI WRIST FUSION SYSTEM (August 17, 1999)

Other clearances for product code KWI

  • K233592 — BioPoly Radial Head Implant (March 13, 2024)
  • K231188 — ALIGN Radial Head System (September 28, 2023)
  • K213563 — DePuy Synthes Radial Head Replacement System (March 18, 2022)
  • K212872 — Avenger Radial Head System (December 17, 2021)
  • K192754 — Avenger Radial Head System (January 7, 2020)
  • K183618 — Revolution Radial Head (May 17, 2019)
  • K172688 — Align Radial Head System (December 22, 2017)
  • K132735 — AXIA RADIAL HEAD SYSTEM (January 7, 2014)
  • K131845 — ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUM (September 30, 2013)
  • K112030 — SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (June 19, 2012)