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510(k) K190970

PROSTEP™ TBI™ (Tailors Bunion Implant) System by Wrightmedicaltechnologyinc — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2019
Date Received
April 12, 2019
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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