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FDA 510(k)

CraniUS Plate

K-Number: K261058 · 2026-07-29

ApplicantCraniUS, LLC
Decision Date2026-07-29
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CraniUS Plate is the device name listed in this FDA 510(k) record. The listed applicant is CraniUS, LLC. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K261058. 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 CraniUS Plate?

CraniUS Plate is a medical device that received FDA 510(k) clearance on 2026-07-29. The listed applicant is CraniUS, LLC. The 510(k) number is K261058.

When did CraniUS Plate receive FDA 510(k) clearance?

CraniUS Plate received FDA 510(k) clearance on 2026-07-29, under 510(k) number K261058.

Who is the listed applicant for CraniUS Plate?

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

What is the FDA product code for CraniUS Plate?

The FDA product code for CraniUS Plate is GWO.

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.

K250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, 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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