Cleared Traditional

Asnis? III Cannulated Screw System and Asnis? PRO Cannulated Screw System

K213199 · Stryker GmbH · Orthopedic
Jan 2022
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K213199 is an FDA 510(k) clearance for the Asnis? III Cannulated Screw System and Asnis? PRO Cannulated Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Stryker GmbH (Malwah, US). The FDA issued a Cleared decision on January 11, 2022, 104 days after receiving the submission on September 29, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K213199 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date January 11, 2022
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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