OIC Intramedullary Screw System
K-Number: K223761 · 2023-02-13
ApplicantOrthopaedic Implant Company
Decision Date2023-02-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OIC Intramedullary Screw System is a medical device manufactured by Orthopaedic Implant Company. It received FDA 510(k) clearance on 2023-02-13 under approval number K223761. 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 OIC Intramedullary Screw System?
OIC Intramedullary Screw System is a medical device that received FDA 510(k) clearance on 2023-02-13. It is manufactured by Orthopaedic Implant Company. The 510(k) number is K223761.
When was OIC Intramedullary Screw System approved by the FDA?
OIC Intramedullary Screw System received FDA 510(k) clearance on 2023-02-13, under approval number K223761.
What company makes OIC Intramedullary Screw System?
OIC Intramedullary Screw System is manufactured by Orthopaedic Implant Company.
What is the FDA product code for OIC Intramedullary Screw System?
The FDA product code for OIC Intramedullary Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
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