Cleared Traditional

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

K214109 · Kontour(Xi?An) Medical Technology Co., Ltd. · Neurology
Oct 2022
Decision
303d
Days
Class 2
Risk

About This 510(k) Submission

K214109 is an FDA 510(k) clearance for the PEEK Patient Specific Cranial/Craniofacial Implant(PSCI), a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Kontour(Xi?An) Medical Technology Co., Ltd. (Xi'An, CN). The FDA issued a Cleared decision on October 28, 2022, 303 days after receiving the submission on December 29, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K214109 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2021
Decision Date October 28, 2022
Days to Decision 303 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXN — Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5330

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