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FDA 510(k)

Overwatch Spine System

K-Number: K161842 · 2016-10-13

ApplicantAmendia, Inc.
Decision Date2016-10-13
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Overwatch Spine System is a medical device manufactured by Amendia, Inc.. It received FDA 510(k) clearance on 2016-10-13 under approval number K161842. 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 Overwatch Spine System?

Overwatch Spine System is a medical device that received FDA 510(k) clearance on 2016-10-13. It is manufactured by Amendia, Inc.. The 510(k) number is K161842.

When was Overwatch Spine System approved by the FDA?

Overwatch Spine System received FDA 510(k) clearance on 2016-10-13, under approval number K161842.

What company makes Overwatch Spine System?

Overwatch Spine System is manufactured by Amendia, Inc..

What is the FDA product code for Overwatch Spine System?

The FDA product code for Overwatch Spine System is NKB.

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Other Devices by Amendia, Inc.

K160924Amendia Interbody Fusion Devices K152920Savannah-T® Pedicle Screw System K153152Syzygy Stabilization System K160291Optimus ALIF System K152972Amendia Stand-Alone Cervical System K151310Amendia Interbody Fusion Devices

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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.

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