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FDA 510(k)

Stryker PEEK Customized Cranial Implant Kit

K-Number: K190229 · 2019-07-11

ApplicantStryker
Decision Date2019-07-11
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker PEEK Customized Cranial Implant Kit is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2019-07-11 under 510(k) number K190229. 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 Stryker PEEK Customized Cranial Implant Kit?

Stryker PEEK Customized Cranial Implant Kit is a medical device that received FDA 510(k) clearance on 2019-07-11. The listed applicant is Stryker. The 510(k) number is K190229.

When did Stryker PEEK Customized Cranial Implant Kit receive FDA 510(k) clearance?

Stryker PEEK Customized Cranial Implant Kit received FDA 510(k) clearance on 2019-07-11, under 510(k) number K190229.

Who is the listed applicant for Stryker PEEK Customized Cranial Implant Kit?

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

What is the FDA product code for Stryker PEEK Customized Cranial Implant Kit?

The FDA product code for Stryker PEEK Customized Cranial Implant Kit is GWO.

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.

NCT05362370Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and EffectivenessACTIVE_NOT_RECRUITINGNCT03895489Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty ProsthesesCOMPLETEDNCT06941558The UK ADAPTIS StudyACTIVE_NOT_RECRUITINGNCT07221916Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow UpCOMPLETEDNCT07245758Facial iD Customized Mandible Reconstruction PlatesCOMPLETEDNCT07647354Mako-MORE RegistryNOT_YET_RECRUITING

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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.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.

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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