FDA 510(k)

Sterispine PS

K-Number: K201648 · 2020-07-30

Decision Date2020-07-30

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Sterispine PS is a medical device manufactured by Safe Orthopaedics. It received FDA 510(k) clearance on 2020-07-30 under approval number K201648. 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 Sterispine PS?

Sterispine PS is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Safe Orthopaedics. The 510(k) number is K201648.

When was Sterispine PS approved by the FDA?

Sterispine PS received FDA 510(k) clearance on 2020-07-30, under approval number K201648.

What company makes Sterispine PS?

Sterispine PS is manufactured by Safe Orthopaedics.

What is the FDA product code for Sterispine PS?

The FDA product code for Sterispine PS is NKB.

Other Devices by Safe Orthopaedics

K162531STERISPINE CC K170528Sterispine PS

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.