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510(k) K101170

ACUTE INNOVATIONS STERNAL FIXATION SYSTEM by Acute Innovations, LLC — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2010
Date Received
April 26, 2010
Clearance Type
Traditional
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

Other clearances by Acute Innovations, LLC

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  • K081588 — RE-ZORB PLATING SYSTEM (September 3, 2008)
  • K061206 — ACUTE BONE SCREW (June 19, 2006)

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