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510(k) K132912

DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT by In2bones Sas — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2014
Date Received
September 17, 2013
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

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