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FDA 510(k)

Stryker Facial iD System

K-Number: K232350 · 2024-01-13

ApplicantStryker Craniomaxillofacial
Decision Date2024-01-13
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stryker Facial iD System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Craniomaxillofacial. It received FDA 510(k) clearance on 2024-01-13 under 510(k) number K232350. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Facial iD System?

Stryker Facial iD System is a medical device that received FDA 510(k) clearance on 2024-01-13. The listed applicant is Stryker Craniomaxillofacial. The 510(k) number is K232350.

When did Stryker Facial iD System receive FDA 510(k) clearance?

Stryker Facial iD System received FDA 510(k) clearance on 2024-01-13, under 510(k) number K232350.

Who is the listed applicant for Stryker Facial iD System?

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

What is the FDA product code for Stryker Facial iD System?

The FDA product code for Stryker Facial iD System is JEY.

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_RECRUITING

Related Devices (Code: JEY)

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.

K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.K240651MRI UniversalStryker 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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