Mbrace Cable
FDA 510(k) K232733 · Medacta International S.A.
510(k) numberK232733
Submission
- Device name
- Mbrace Cable
- Applicant
- Medacta International S.A.
Castel San Pietro, CH - Received
- September 7, 2023
- Decision date
- May 3, 2024
- 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 Mbrace Cable cleared by the FDA?
Mbrace Cable (K232733) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 239 days after the submission was received.
What is the product code of K232733?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.