Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System

FDA 510(k) K151848 · Zimmer, Inc.

Substantially Equivalent

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

Official FDA 510(k) record

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.