Bright Guard
K-Number: K181099 · 2019-01-18
ApplicantKoncept Innovators, LLC
Decision Date2019-01-18
Product CodeOBR
DecisionSubstantially Equivalent
Device Summary
Bright Guard is a medical device manufactured by Koncept Innovators, LLC. It received FDA 510(k) clearance on 2019-01-18 under approval number K181099. 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 Bright Guard?
Bright Guard is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Koncept Innovators, LLC. The 510(k) number is K181099.
When was Bright Guard approved by the FDA?
Bright Guard received FDA 510(k) clearance on 2019-01-18, under approval number K181099.
What company makes Bright Guard?
Bright Guard is manufactured by Koncept Innovators, LLC.
What is the FDA product code for Bright Guard?
The FDA product code for Bright Guard is OBR. This falls under the Orthopedic category.
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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.