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FDA 510(k)

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

K-Number: K214109 · 2022-10-28

ApplicantKontour(Xi’An) Medical Technology Co., Ltd.
Decision Date2022-10-28
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is the device name listed in this FDA 510(k) record. The listed applicant is Kontour(Xi’An) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K214109. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Kontour(Xi’An) Medical Technology Co., Ltd.. The 510(k) number is K214109.

When did PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) receive FDA 510(k) clearance?

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) received FDA 510(k) clearance on 2022-10-28, under 510(k) number K214109.

Who is the listed applicant for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

The FDA 510(k) record lists Kontour(Xi’An) Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

The FDA product code for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is GXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05362370Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and EffectivenessACTIVE_NOT_RECRUITING

Related Devices (Code: GXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.K243715Synthes Patient Specific ImplantsSynthes GmbHK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEKLS-Martin L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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