Spinal fixation system

FDA 510(k) K161151 · Canwell Medical Co., Ltd.

Substantially Equivalent

510(k) numberK161151

Submission

Device name
Spinal fixation system
Applicant
Canwell Medical Co., Ltd.
Jinhua, CN
Received
April 25, 2016
Decision date
September 21, 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
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

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K162066Reliance Spinal Screw SystemMNH · Traditional Reliance Medical Systems, LLC12/02/2016SE
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K162143FixxSure® X-LinkMNH · Traditional Innovasis, Inc.09/23/2016SE
K162189ANAX™ 5.5 Spinal SystemMNH · Special U&I Corporation08/30/2016SE
K151362HC Spinal SystemMNH · Traditional Hung Chun Bio-S Co., Ltd.05/05/2016SE
K153404Zavation Spinal SystemMNH · Traditional Zavation, LLC04/21/2016SE
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
K151116CapLOX II/TowerLOX Pedicle Screw SystemMNH · Special Captiva Spine06/26/2015SE

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Questions and answers

When was Spinal fixation system cleared by the FDA?

Spinal fixation system (K161151) received a 510(k) decision of Substantially Equivalent on September 21, 2016, 149 days after the submission was received.

What is the product code of K161151?

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