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510(k) K214109

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) by Kontour(Xi’An) Medical Technology Co., Ltd. — Product Code GXN

K214109 is an FDA 510(k) premarket notification submitted by Kontour(Xi’An) Medical Technology Co., Ltd. for the device "PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)". The FDA issued a decision of Substantially Equivalent on October 28, 2022. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2022
Date Received
December 29, 2021
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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FDA data resources