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510(k) K143204

AOS Clavicle Intramedullary Device by Advanced Orthopaedic Solutions, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2015
Date Received
November 7, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

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  • K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FI (October 29, 2014)
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  • K133081 — TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEG (December 31, 2013)
  • K132005 — RETROGRADE FEMORAL NAIL (September 10, 2013)
  • K123569 — ANTEGRADE FEMORAL NAIL (May 24, 2013)

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