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FDA 510(k)

Boundary Anterior Lumbar Buttress Plate

K-Number: K173091 · 2017-12-06

ApplicantNvision Biomedical Technologies, LLC
Decision Date2017-12-06
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Boundary Anterior Lumbar Buttress Plate is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2017-12-06 under 510(k) number K173091. 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 Boundary Anterior Lumbar Buttress Plate?

Boundary Anterior Lumbar Buttress Plate is a medical device that received FDA 510(k) clearance on 2017-12-06. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K173091.

When did Boundary Anterior Lumbar Buttress Plate receive FDA 510(k) clearance?

Boundary Anterior Lumbar Buttress Plate received FDA 510(k) clearance on 2017-12-06, under 510(k) number K173091.

Who is the listed applicant for Boundary Anterior Lumbar Buttress Plate?

The FDA 510(k) record lists Nvision Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boundary Anterior Lumbar Buttress Plate?

The FDA product code for Boundary Anterior Lumbar Buttress Plate is 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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