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510(k) K981757

SYNTHES (USA) DHS HELIX SYSTEM by Synthes (Usa) — Product Code JDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1998
Date Received
May 19, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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