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510(k) K142707

AIS Odontoid Fracture Fixation System by Aesculap Implant System, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2014
Date Received
September 22, 2014
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

Other clearances by Aesculap Implant System, Inc.

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  • K130887 — S4C NAVIGATION INSTRUMENTS (August 13, 2013)
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  • K130291 — S4 SPINAL SYSTEM (April 11, 2013)
  • K122985 — COLUMBUS REVISION KNEE SYSTEM (October 26, 2012)
  • K112551 — S4 SPINAL SYSTEM (November 21, 2011)
  • K101281 — VEGA KNEE SYSTEM (July 30, 2010)
  • K100147 — S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (July 23, 2010)

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