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FDA 510(k)

Fusion Craniofacial Implant; Fusion Skull Implant

K-Number: K250334 · 2025-07-25

ApplicantKelyniam Global, Inc.
Decision Date2025-07-25
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Fusion Craniofacial Implant; Fusion Skull Implant 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 2025-07-25 under 510(k) number K250334. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fusion Craniofacial Implant; Fusion Skull Implant?

Fusion Craniofacial Implant; Fusion Skull Implant is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Kelyniam Global, Inc.. The 510(k) number is K250334.

When did Fusion Craniofacial Implant; Fusion Skull Implant receive FDA 510(k) clearance?

Fusion Craniofacial Implant; Fusion Skull Implant received FDA 510(k) clearance on 2025-07-25, under 510(k) number K250334.

Who is the listed applicant for Fusion Craniofacial Implant; Fusion Skull Implant?

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 Fusion Craniofacial Implant; Fusion Skull Implant?

The FDA product code for Fusion Craniofacial Implant; Fusion Skull Implant is GWO.

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.

K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

Related Devices (Code: GWO)

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.

K261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)Osteonic Co., Ltd.K203055Stryker PEEK Customized Cranial Implant KitStryker

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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