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510(k) K040356

KOMPRESSOR SCREW SYSTEM by Kinetikos Medical, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2004
Date Received
February 13, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
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)
  • K032806 — KATALYST RADIAL HEAD IMPLANT (April 16, 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)

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