c1Trac
FDA 510(k) K222912 · Zimmer Medizinsysteme GmbH
510(k) numberK222912
Submission
- Device name
- c1Trac
- Applicant
- Zimmer Medizinsysteme GmbH
Neu-Ulm, DE - Received
- September 26, 2022
- Decision date
- May 16, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITH – Equipment, Traction, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5900
- Specialty
- Physical Medicine
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Questions and answers
When was c1Trac cleared by the FDA?
c1Trac (K222912) received a 510(k) decision of Substantially Equivalent on May 16, 2023, 232 days after the submission was received.
What is the product code of K222912?
The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.