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510(k) K222650

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate by Stryker Craniomaxillofacial (Cmf) — Product Code JEY

K222650 is an FDA 510(k) premarket notification submitted by Stryker Craniomaxillofacial (Cmf) for the device "Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate". The FDA issued a decision of Substantially Equivalent on December 9, 2022. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2022
Date Received
September 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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FDA data resources