Biomet Cable System
FDA 510(k) K071271 · Biomet Manufacturing, Inc.
510(k) numberK071271
Submission
- Device name
- Biomet Cable System
- Applicant
- Biomet Manufacturing, Inc.
Warsaw, IN, US - Received
- May 7, 2007
- Decision date
- October 23, 2007
- 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 Biomet Cable System cleared by the FDA?
Biomet Cable System (K071271) received a 510(k) decision of Substantially Equivalent on October 23, 2007, 169 days after the submission was received.
What is the product code of K071271?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.