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510(k) K131005

EBA2 FEMORAL NAILING SYSTEM by Citieffe S.R.L. — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2013
Date Received
April 11, 2013
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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  • K113384 — EXTERNAL FIXATOR ST.A R 90 F4 (May 1, 2012)
  • K113387 — CITIEFFE TITANIUM NAILING SYSTEM (March 15, 2012)

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