Bone Bolt System
K-Number: K230867 · 2023-06-26
Decision Date2023-06-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Bone Bolt System is a medical device manufactured by University of Utah, Department of Orthopaedics. It received FDA 510(k) clearance on 2023-06-26 under approval number K230867. 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 Bone Bolt System?
Bone Bolt System is a medical device that received FDA 510(k) clearance on 2023-06-26. It is manufactured by University of Utah, Department of Orthopaedics. The 510(k) number is K230867.
When was Bone Bolt System approved by the FDA?
Bone Bolt System received FDA 510(k) clearance on 2023-06-26, under approval number K230867.
What company makes Bone Bolt System?
Bone Bolt System is manufactured by University of Utah, Department of Orthopaedics.
What is the FDA product code for Bone Bolt System?
The FDA product code for Bone Bolt System is HWC. This falls under the Cardiovascular category.
Other Devices by University of Utah, Department of Orthopaedics
Related Devices (Code: HWC)
K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P.
K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific
K161778ToeTac 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek
K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC
K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.
K161449HammerTech Fixation SystemFusion Orthopedics, LLC
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.