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510(k) K190670

ORTHOLOC™ 2 Lapidus with Rotation System by Wrightmedicaltechnologyinc — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2019
Date Received
March 15, 2019
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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