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510(k) K150661

ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite by Citieffe S.R.L. — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2015
Date Received
March 13, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K131005 — EBA2 FEMORAL NAILING SYSTEM (June 25, 2013)
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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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