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510(k) K212755

SIGNUS SACRONAIL® Transsacral Stabilization System by Signus Medizintechnik GmbH — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2022
Date Received
August 31, 2021
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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