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510(k) K093550

MINI RAIL EXTERNAL FIXATOR SYSTEM by Small Bone Innovations, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2010
Date Received
November 17, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K071540 — SBI TITANIUM THREADED PIN (August 8, 2007)
  • K071549 — SBI RHEAD PLATING SYSTEM (August 7, 2007)

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