OsteoCentric ACL Fixation System
K-Number: K230595 · 2023-06-29
ApplicantOsteoCentric Technologies
Decision Date2023-06-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OsteoCentric ACL Fixation System is a medical device manufactured by OsteoCentric Technologies. It received FDA 510(k) clearance on 2023-06-29 under approval number K230595. 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 OsteoCentric ACL Fixation System?
OsteoCentric ACL Fixation System is a medical device that received FDA 510(k) clearance on 2023-06-29. It is manufactured by OsteoCentric Technologies. The 510(k) number is K230595.
When was OsteoCentric ACL Fixation System approved by the FDA?
OsteoCentric ACL Fixation System received FDA 510(k) clearance on 2023-06-29, under approval number K230595.
What company makes OsteoCentric ACL Fixation System?
OsteoCentric ACL Fixation System is manufactured by OsteoCentric Technologies.
What is the FDA product code for OsteoCentric ACL Fixation System?
The FDA product code for OsteoCentric ACL Fixation 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.