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510(k) K222820

BRM TOOL Screws, BIOPLAN Subtalar Implant by Brm Extremities — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2022
Date Received
September 19, 2022
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

Other clearances by Brm Extremities

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