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510(k) K183620

PROSTEP TBC Implant System by Wrightmedicaltechnologyinc — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2019
Date Received
December 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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