FDA 510(k)

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate

K-Number: K222650 · 2022-12-09

ApplicantStryker Craniomaxillofacial (Cmf)

Decision Date2022-12-09

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Craniomaxillofacial (Cmf). It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K222650. 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 Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Stryker Craniomaxillofacial (Cmf). The 510(k) number is K222650.

When did Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate receive FDA 510(k) clearance?

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate received FDA 510(k) clearance on 2022-12-09, under 510(k) number K222650.

Who is the listed applicant for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

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

What is the FDA product code for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate?

The FDA product code for Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate 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.

NCT07221916Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow UpCOMPLETED

Related Devices (Code: JEY)

K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical Corporation K253373Southern 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 OY K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.K240651MRI UniversalStryker Leibinger GmbH & Co KG

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.