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 a medical device manufactured by Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2016-05-20 under approval 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. It is manufactured by Reliance Medical Systems, LLC. The 510(k) number is K160463.
When was Reliance Lumbar IBF System approved by the FDA?
Reliance Lumbar IBF System received FDA 510(k) clearance on 2016-05-20, under approval number K160463.
What company makes Reliance Lumbar IBF System?
Reliance Lumbar IBF System is manufactured by Reliance Medical Systems, LLC.
What is the FDA product code for Reliance Lumbar IBF System?
The FDA product code for Reliance Lumbar IBF System is MAX.
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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.