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510(k) K180249

OmniPore DUROMAX Surgical Implants by Matrix Surgical Holdings, LLC/Matrix Surgical USA — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2018
Date Received
January 29, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by Matrix Surgical Holdings, LLC/Matrix Surgical USA

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