FDA 510(k)

LOSPA® IS Spinal Fixation System

K-Number: K200267 · 2020-03-06

Decision Date2020-03-06

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LOSPA® IS Spinal Fixation System is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2020-03-06 under approval number K200267. 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 LOSPA® IS Spinal Fixation System?

LOSPA® IS Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-03-06. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K200267.

When was LOSPA® IS Spinal Fixation System approved by the FDA?

LOSPA® IS Spinal Fixation System received FDA 510(k) clearance on 2020-03-06, under approval number K200267.

What company makes LOSPA® IS Spinal Fixation System?

LOSPA® IS Spinal Fixation System is manufactured by Corentec Co., Ltd..

What is the FDA product code for LOSPA® IS Spinal Fixation System?

The FDA product code for LOSPA® IS Spinal Fixation System is NKB.

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Related PubMed Literature

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Other Devices by Corentec Co., Ltd.

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup System K160157LOSPA Modular Knee System K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug K172806Bencox Mirabo Cup System K170243LOSPA IS TLIF & DLIF Cages K161641LOSPA IS ACP System

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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.