Cleared Traditional

c1Trac

K222912 · Zimmer Medizinsysteme GmbH · Physical Medicine
May 2023
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K222912 is an FDA 510(k) clearance for the c1Trac, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Zimmer Medizinsysteme GmbH (Neu-Ulm, DE). The FDA issued a Cleared decision on May 16, 2023, 232 days after receiving the submission on September 26, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number K222912 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2022
Decision Date May 16, 2023
Days to Decision 232 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ITH — Equipment, Traction, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5900

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