Cleared Traditional

Stryker Facial iD System

K232350 · Stryker Craniomaxillofacial · Dental
Jan 2024
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K232350 is an FDA 510(k) clearance for the Stryker Facial iD System, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Stryker Craniomaxillofacial (Kalamazoo, US). The FDA issued a Cleared decision on January 13, 2024, 159 days after receiving the submission on August 7, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K232350 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2023
Decision Date January 13, 2024
Days to Decision 159 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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