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FDA 510(k)

PEEK Customized Cranial Implant

K-Number: K153248 · 2016-03-10

ApplicantStryker
Decision Date2016-03-10
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PEEK Customized Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K153248. 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 PEEK Customized Cranial Implant?

PEEK Customized Cranial Implant is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Stryker. The 510(k) number is K153248.

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

PEEK Customized Cranial Implant received FDA 510(k) clearance on 2016-03-10, under 510(k) number K153248.

Who is the listed applicant for PEEK Customized Cranial Implant?

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 PEEK Customized Cranial Implant?

The FDA product code for PEEK Customized Cranial Implant 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_RECRUITINGNCT07679451Custom-Made PEEK Versus PTFE Membranes in Maxillary Alveolar Ridge AugmentationRECRUITING

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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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