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510(k) K103533

ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM by Advanced Orthopaedic Solutions, Inc. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2011
Date Received
December 1, 2010
Clearance Type
Special
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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  • K133081 — TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEG (December 31, 2013)
  • K132005 — RETROGRADE FEMORAL NAIL (September 10, 2013)

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