IntraLock System
K-Number: K210159 · 2021-07-23
ApplicantFusion Orthopedics, LLC
Decision Date2021-07-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
IntraLock System is a medical device manufactured by Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2021-07-23 under approval number K210159. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IntraLock System?
IntraLock System is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Fusion Orthopedics, LLC. The 510(k) number is K210159.
When was IntraLock System approved by the FDA?
IntraLock System received FDA 510(k) clearance on 2021-07-23, under approval number K210159.
What company makes IntraLock System?
IntraLock System is manufactured by Fusion Orthopedics, LLC.
What is the FDA product code for IntraLock System?
The FDA product code for IntraLock System is HWC. This falls under the Cardiovascular 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.