Cleared Traditional

Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System

K220319 · Stryker GmbH · Orthopedic
Jun 2022
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K220319 is an FDA 510(k) clearance for the Asnis III Cannulated Screw System, 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 June 10, 2022, 127 days after receiving the submission on February 3, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K220319 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2022
Decision Date June 10, 2022
Days to Decision 127 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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