Synthes Sternal Zipfix System
FDA 510(k) K110789 · Synthes (Usa)
510(k) numberK110789
Submission
- Device name
- Synthes Sternal Zipfix System
- Applicant
- Synthes (Usa)
West Chester, PA, US - Received
- March 22, 2011
- Decision date
- July 28, 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 Synthes Sternal Zipfix System cleared by the FDA?
Synthes Sternal Zipfix System (K110789) received a 510(k) decision of Substantially Equivalent on July 28, 2011, 128 days after the submission was received.
What is the product code of K110789?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.