Home / 510(k) Clearances / K143661

510(k) K143661

DirectInject by Stryker — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2015
Date Received
December 23, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

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