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FDA 510(k)

KELYNIAM CUSTOM SKULL IMPLANT (CSI)

K-Number: K103582 · 2011-04-14

ApplicantKelyniam Global, Inc.
Decision Date2011-04-14
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KELYNIAM CUSTOM SKULL IMPLANT (CSI) 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 2011-04-14 under 510(k) number K103582. 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 KELYNIAM CUSTOM SKULL IMPLANT (CSI)?

KELYNIAM CUSTOM SKULL IMPLANT (CSI) is a medical device that received FDA 510(k) clearance on 2011-04-14. The listed applicant is Kelyniam Global, Inc.. The 510(k) number is K103582.

When did KELYNIAM CUSTOM SKULL IMPLANT (CSI) receive FDA 510(k) clearance?

KELYNIAM CUSTOM SKULL IMPLANT (CSI) received FDA 510(k) clearance on 2011-04-14, under 510(k) number K103582.

Who is the listed applicant for KELYNIAM CUSTOM SKULL IMPLANT (CSI)?

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 KELYNIAM CUSTOM SKULL IMPLANT (CSI)?

The FDA product code for KELYNIAM CUSTOM SKULL IMPLANT (CSI) 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)K121755CUSTOM CRANIOFACIAL IMPLANT (CCI)

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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