Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
FDA 510(k) K151848 · Zimmer, Inc.
510(k) numberK151848
Submission
- Device name
- Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- July 7, 2015
- Decision date
- January 15, 2016
- 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 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System cleared by the FDA?
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System (K151848) received a 510(k) decision of Substantially Equivalent on January 15, 2016, 192 days after the submission was received.
What is the product code of K151848?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.