FDA 510(k)

Bruxor

K-Number: K172452 · 2018-01-11

Decision Date2018-01-11

Product CodeOBR

DecisionSubstantially Equivalent

Device Summary

Bruxor is a medical device manufactured by Sleep Specialties, LLC. It received FDA 510(k) clearance on 2018-01-11 under approval number K172452. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bruxor?

Bruxor is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Sleep Specialties, LLC. The 510(k) number is K172452.

When was Bruxor approved by the FDA?

Bruxor received FDA 510(k) clearance on 2018-01-11, under approval number K172452.

What company makes Bruxor?

Bruxor is manufactured by Sleep Specialties, LLC.

What is the FDA product code for Bruxor?

The FDA product code for Bruxor is OBR. This falls under the Orthopedic category.

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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.