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FDA 510(k)

Syzygy Stabilization System

K-Number: K153152 · 2016-04-27

ApplicantAmendia, Inc.
Decision Date2016-04-27
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Syzygy Stabilization System is a medical device manufactured by Amendia, Inc.. It received FDA 510(k) clearance on 2016-04-27 under approval number K153152. 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 Syzygy Stabilization System?

Syzygy Stabilization System is a medical device that received FDA 510(k) clearance on 2016-04-27. It is manufactured by Amendia, Inc.. The 510(k) number is K153152.

When was Syzygy Stabilization System approved by the FDA?

Syzygy Stabilization System received FDA 510(k) clearance on 2016-04-27, under approval number K153152.

What company makes Syzygy Stabilization System?

Syzygy Stabilization System is manufactured by Amendia, Inc..

What is the FDA product code for Syzygy Stabilization System?

The FDA product code for Syzygy Stabilization System is NKB.

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Other Devices by Amendia, Inc.

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Related Devices (Code: NKB)

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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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