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FDA 510(k)

OAKTREE Anterior Lumbar Plate and Screw System

K-Number: K220843 · 2022-12-07

ApplicantOak Tree Engineering, LLC
Decision Date2022-12-07
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OAKTREE Anterior Lumbar Plate and Screw System is a medical device manufactured by Oak Tree Engineering, LLC. It received FDA 510(k) clearance on 2022-12-07 under approval number K220843. 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 OAKTREE Anterior Lumbar Plate and Screw System?

OAKTREE Anterior Lumbar Plate and Screw System is a medical device that received FDA 510(k) clearance on 2022-12-07. It is manufactured by Oak Tree Engineering, LLC. The 510(k) number is K220843.

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

OAKTREE Anterior Lumbar Plate and Screw System received FDA 510(k) clearance on 2022-12-07, under approval number K220843.

What company makes OAKTREE Anterior Lumbar Plate and Screw System?

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

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

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

Related Clinical Trials

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Other Devices by Oak Tree Engineering, LLC

K211932Fixxsure Anterior Lumbar Plate and Screw System

Related Devices (Code: KWQ)

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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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