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510(k) K192702

DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional by Synthes (USA) Products, LLC — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2020
Date Received
September 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

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  • K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional (December 30, 2019)

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