ClenchGuard
K-Number: K181005 · 2020-01-15
ApplicantBoyd Research, Inc.
Decision Date2020-01-15
Product CodeOBR
DecisionSubstantially Equivalent
Device Summary
ClenchGuard is a medical device manufactured by Boyd Research, Inc.. It received FDA 510(k) clearance on 2020-01-15 under approval number K181005. 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 ClenchGuard?
ClenchGuard is a medical device that received FDA 510(k) clearance on 2020-01-15. It is manufactured by Boyd Research, Inc.. The 510(k) number is K181005.
When was ClenchGuard approved by the FDA?
ClenchGuard received FDA 510(k) clearance on 2020-01-15, under approval number K181005.
What company makes ClenchGuard?
ClenchGuard is manufactured by Boyd Research, Inc..
What is the FDA product code for ClenchGuard?
The FDA product code for ClenchGuard 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.