IBS-B MIS Beveled Screw System
K-Number: K231236 · 2023-07-27
ApplicantIn2bones USA, LLC
Decision Date2023-07-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
IBS-B MIS Beveled Screw System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2023-07-27 under approval number K231236. 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 IBS-B MIS Beveled Screw System?
IBS-B MIS Beveled Screw System is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by In2bones USA, LLC. The 510(k) number is K231236.
When was IBS-B MIS Beveled Screw System approved by the FDA?
IBS-B MIS Beveled Screw System received FDA 510(k) clearance on 2023-07-27, under approval number K231236.
What company makes IBS-B MIS Beveled Screw System?
IBS-B MIS Beveled Screw System is manufactured by In2bones USA, LLC.
What is the FDA product code for IBS-B MIS Beveled Screw System?
The FDA product code for IBS-B MIS Beveled Screw System is HWC. This falls under the Cardiovascular category.
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Official Source
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