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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 a medical device manufactured by Kelyniam Global, Inc.. It received FDA 510(k) clearance on 2025-07-25 under approval 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. It is manufactured by Kelyniam Global, Inc.. The 510(k) number is K250334.

When was Fusion Craniofacial Implant; Fusion Skull Implant approved by the FDA?

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

What company makes Fusion Craniofacial Implant; Fusion Skull Implant?

Fusion Craniofacial Implant; Fusion Skull Implant is manufactured by Kelyniam Global, Inc..

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.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07565545 Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes NOT_YET_RECRUITING NCT05393622 Brain Stimulation for Severe Depression RECRUITING NCT05367505 Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis RECRUITING

Other Devices by Kelyniam Global, Inc.

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

Related Devices (Code: GWO)

K161821Stryker Universal MeshStryker K161446Biopor Porous Polyethylene ImplantsCeremed , Inc. K153248PEEK Customized Cranial ImplantStryker K170725Stryker Universal MeshStryker K170368Sterile NS SystemJeil Medical Corporation K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG

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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