Cleared Traditional

Stryker PEEK Customized Cranial Implant Kit

K203055 · Stryker · Neurology
Feb 2021
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K203055 is an FDA 510(k) clearance for the Stryker PEEK Customized Cranial Implant Kit, a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by Stryker (Portage, US). The FDA issued a Cleared decision on February 9, 2021, 124 days after receiving the submission on October 8, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K203055 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 2020
Decision Date February 09, 2021
Days to Decision 124 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWO — Plate, Cranioplasty, Preformed, Alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5320

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