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510(k) K171628

HBS2 Headless Bone Screw by Stuckenbrock Medizintechnik GmbH — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2018
Date Received
June 2, 2017
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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