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FDA 510(k)

Reliance Lumbar IBF System

K-Number: K160463 · 2016-05-20

ApplicantReliance Medical Systems, LLC
Decision Date2016-05-20
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Reliance Lumbar IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K160463. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reliance Lumbar IBF System?

Reliance Lumbar IBF System is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Reliance Medical Systems, LLC. The 510(k) number is K160463.

When did Reliance Lumbar IBF System receive FDA 510(k) clearance?

Reliance Lumbar IBF System received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160463.

Who is the listed applicant for Reliance Lumbar IBF System?

The FDA 510(k) record lists Reliance Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reliance Lumbar IBF System?

The FDA product code for Reliance Lumbar IBF System is MAX.

Other records listing Reliance Medical Systems, LLC as applicant

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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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