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FDA 510(k)

TREND II Spinal Fixation System- STEP Series

K-Number: K180226 · 2018-07-25

ApplicantPaonan Biotech Co., Ltd.
Decision Date2018-07-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TREND II Spinal Fixation System- STEP Series is a medical device manufactured by Paonan Biotech Co., Ltd.. It received FDA 510(k) clearance on 2018-07-25 under approval number K180226. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TREND II Spinal Fixation System- STEP Series?

TREND II Spinal Fixation System- STEP Series is a medical device that received FDA 510(k) clearance on 2018-07-25. It is manufactured by Paonan Biotech Co., Ltd.. The 510(k) number is K180226.

When was TREND II Spinal Fixation System- STEP Series approved by the FDA?

TREND II Spinal Fixation System- STEP Series received FDA 510(k) clearance on 2018-07-25, under approval number K180226.

What company makes TREND II Spinal Fixation System- STEP Series?

TREND II Spinal Fixation System- STEP Series is manufactured by Paonan Biotech Co., Ltd..

What is the FDA product code for TREND II Spinal Fixation System- STEP Series?

The FDA product code for TREND II Spinal Fixation System- STEP Series is NKB.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Paonan Biotech Co., Ltd.

K161225Paonan Armstrong Posterior Spinal Fixation System K182285PK High Tibial Osteotomy Correction System K180230NEST Interbody System K180228II-Type Intervertebral Spacer K220261NEST-C Interbody System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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