FDA 510(k)

OsseoScrew System

K-Number: K181980 · 2018-09-25

Decision Date2018-09-25

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OsseoScrew System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2018-09-25 under approval number K181980. 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 OsseoScrew System?

OsseoScrew System is a medical device that received FDA 510(k) clearance on 2018-09-25. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K181980.

When was OsseoScrew System approved by the FDA?

OsseoScrew System received FDA 510(k) clearance on 2018-09-25, under approval number K181980.

What company makes OsseoScrew System?

OsseoScrew System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for OsseoScrew System?

The FDA product code for OsseoScrew System is NKB.

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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

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