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510(k) K960692

SUBTALAR MBA SYSTEM by Kinetikos Medical, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1996
Date Received
February 20, 1996
Clearance Type
Traditional
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

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  • 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)

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