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FDA 510(k)

Dymaxeon Spine System

K-Number: K192930 · 2020-05-12

ApplicantBack 2 Basics Direct, LLC
Decision Date2020-05-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dymaxeon Spine System is a medical device manufactured by Back 2 Basics Direct, LLC. It received FDA 510(k) clearance on 2020-05-12 under approval number K192930. 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 Dymaxeon Spine System?

Dymaxeon Spine System is a medical device that received FDA 510(k) clearance on 2020-05-12. It is manufactured by Back 2 Basics Direct, LLC. The 510(k) number is K192930.

When was Dymaxeon Spine System approved by the FDA?

Dymaxeon Spine System received FDA 510(k) clearance on 2020-05-12, under approval number K192930.

What company makes Dymaxeon Spine System?

Dymaxeon Spine System is manufactured by Back 2 Basics Direct, LLC.

What is the FDA product code for Dymaxeon Spine System?

The FDA product code for Dymaxeon Spine System is NKB.

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Other Devices by Back 2 Basics Direct, LLC

K170989Dymaxeon Spine System K191537eCarbon IBDs

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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