K2M Cocr Wire
FDA 510(k) K103797 · K2m, Inc.
510(k) numberK103797
Submission
- Device name
- K2M Cocr Wire
- Applicant
- K2m, Inc.
Leesburg, VA, US - Received
- December 27, 2010
- Decision date
- May 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was K2M Cocr Wire cleared by the FDA?
K2M Cocr Wire (K103797) received a 510(k) decision of Substantially Equivalent on May 20, 2011, 144 days after the submission was received.
What is the product code of K103797?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.