Custom Bars
K-Number: K162633 · 2017-07-24
Decision Date2017-07-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Custom Bars is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2017-07-24 under approval number K162633. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Custom Bars?
Custom Bars is a medical device that received FDA 510(k) clearance on 2017-07-24. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K162633.
When was Custom Bars approved by the FDA?
Custom Bars received FDA 510(k) clearance on 2017-07-24, under approval number K162633.
What company makes Custom Bars?
Custom Bars is manufactured by Implant Direct Sybron Manufacturing, LLC.
What is the FDA product code for Custom Bars?
The FDA product code for Custom Bars is NHA.
Other Devices by Implant Direct Sybron Manufacturing, LLC
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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.