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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K222650
Device Name Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate
Applicant
Stryker Craniomaxillofacial (Cmf)
1941 Stryker Way
Portage,  MI  49002
Applicant Contact Zainab Amini
Correspondent
Stryker Craniomaxillofacial (Cmf)
1941 Stryker Way
Portage,  MI  49002
Correspondent Contact Zainab Amini
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/01/2022
Decision Date 12/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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