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FDA 510(k)

CUSTOM CRANIOFACIAL IMPLANT (CCI)

K-Number: K121755 · 2012-09-25

ApplicantKelyniam Global, Inc.
Decision Date2012-09-25
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CUSTOM CRANIOFACIAL IMPLANT (CCI) is the device name listed in this FDA 510(k) record. The listed applicant is Kelyniam Global, Inc.. It received FDA 510(k) clearance on 2012-09-25 under 510(k) number K121755. 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 CUSTOM CRANIOFACIAL IMPLANT (CCI)?

CUSTOM CRANIOFACIAL IMPLANT (CCI) is a medical device that received FDA 510(k) clearance on 2012-09-25. The listed applicant is Kelyniam Global, Inc.. The 510(k) number is K121755.

When did CUSTOM CRANIOFACIAL IMPLANT (CCI) receive FDA 510(k) clearance?

CUSTOM CRANIOFACIAL IMPLANT (CCI) received FDA 510(k) clearance on 2012-09-25, under 510(k) number K121755.

Who is the listed applicant for CUSTOM CRANIOFACIAL IMPLANT (CCI)?

The FDA 510(k) record lists Kelyniam Global, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTOM CRANIOFACIAL IMPLANT (CCI)?

The FDA product code for CUSTOM CRANIOFACIAL IMPLANT (CCI) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kelyniam Global, Inc. as applicant

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.

K250334Fusion Craniofacial Implant; Fusion Skull ImplantK182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)K103582KELYNIAM CUSTOM SKULL IMPLANT (CSI)

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

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

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