HC Spinal System

FDA 510(k) K151362 · Hung Chun Bio-S Co., Ltd.

Substantially Equivalent

510(k) numberK151362

Submission

Device name
HC Spinal System
Applicant
Hung Chun Bio-S Co., Ltd.
Kaohsiung, TW
Received
May 21, 2015
Decision date
May 5, 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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K161151Spinal fixation systemMNH · Traditional Canwell Medical Co., Ltd.09/21/2016SE
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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 HC Spinal System cleared by the FDA?

HC Spinal System (K151362) received a 510(k) decision of Substantially Equivalent on May 5, 2016, 350 days after the submission was received.

What is the product code of K151362?

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