KangLi pedical screw spinal system

FDA 510(k) K142290 · Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Substantially Equivalent

510(k) numberK142290

Submission

Device name
KangLi pedical screw spinal system
Applicant
Suzhou Kangli Orthopaedics Instrument Co., Ltd.
Zhangjiagang City, CN
Received
August 18, 2014
Decision date
November 24, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

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K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special Captiva Spine03/02/2016SE
K143013Spinal Inner Fixation SystemMNH · Traditional Changzhou Dingjian Medical Appliance Co., Ltd.12/11/2015SE
K151695Romeo posterior osteosynthesis systemMNH · Traditional Spineart09/10/2015SE

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Questions and answers

When was KangLi pedical screw spinal system cleared by the FDA?

KangLi pedical screw spinal system (K142290) received a 510(k) decision of Substantially Equivalent on November 24, 2014, 98 days after the submission was received.

What is the product code of K142290?

The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.