NTI ClenchGuard
K-Number: K211158 · 2021-09-17
ApplicantBoyd Research, Inc.
Decision Date2021-09-17
Product CodeOBR
DecisionSubstantially Equivalent
Device Summary
NTI ClenchGuard is a medical device manufactured by Boyd Research, Inc.. It received FDA 510(k) clearance on 2021-09-17 under approval number K211158. 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 NTI ClenchGuard?
NTI ClenchGuard is a medical device that received FDA 510(k) clearance on 2021-09-17. It is manufactured by Boyd Research, Inc.. The 510(k) number is K211158.
When was NTI ClenchGuard approved by the FDA?
NTI ClenchGuard received FDA 510(k) clearance on 2021-09-17, under approval number K211158.
What company makes NTI ClenchGuard?
NTI ClenchGuard is manufactured by Boyd Research, Inc..
What is the FDA product code for NTI ClenchGuard?
The FDA product code for NTI 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.