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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 the device name listed in this FDA 510(k) record. The listed applicant is Oak Tree Engineering, LLC. It received FDA 510(k) clearance on 2022-12-07 under 510(k) 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. The listed applicant is Oak Tree Engineering, LLC. The 510(k) number is K220843.

When did OAKTREE Anterior Lumbar Plate and Screw System receive FDA 510(k) clearance?

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

Who is the listed applicant for OAKTREE Anterior Lumbar Plate and Screw System?

The FDA 510(k) record lists Oak Tree Engineering, LLC as the applicant. This does not by itself establish the device manufacturer.

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 records listing Oak Tree Engineering, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211932Fixxsure Anterior Lumbar Plate and Screw System

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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