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FDA 510(k)

Fixxsure Anterior Lumbar Plate and Screw System

K-Number: K211932 · 2021-07-27

ApplicantOak Tree Engineering, LLC
Decision Date2021-07-27
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fixxsure Anterior Lumbar Plate and Screw System is a medical device manufactured by Oak Tree Engineering, LLC. It received FDA 510(k) clearance on 2021-07-27 under approval number K211932. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fixxsure Anterior Lumbar Plate and Screw System?

Fixxsure Anterior Lumbar Plate and Screw System is a medical device that received FDA 510(k) clearance on 2021-07-27. It is manufactured by Oak Tree Engineering, LLC. The 510(k) number is K211932.

When was Fixxsure Anterior Lumbar Plate and Screw System approved by the FDA?

Fixxsure Anterior Lumbar Plate and Screw System received FDA 510(k) clearance on 2021-07-27, under approval number K211932.

What company makes Fixxsure Anterior Lumbar Plate and Screw System?

Fixxsure Anterior Lumbar Plate and Screw System is manufactured by Oak Tree Engineering, LLC.

What is the FDA product code for Fixxsure Anterior Lumbar Plate and Screw System?

The FDA product code for Fixxsure Anterior Lumbar Plate and Screw System is KWQ.

Related Clinical Trials

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Other Devices by Oak Tree Engineering, LLC

K220843OAKTREE Anterior Lumbar Plate and Screw System

Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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