Fracture and Correction System
K-Number: K180377 · 2018-06-20
ApplicantIn2bones USA, LLC
Decision Date2018-06-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fracture and Correction System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2018-06-20 under approval number K180377. 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 Fracture and Correction System?
Fracture and Correction System is a medical device that received FDA 510(k) clearance on 2018-06-20. It is manufactured by In2bones USA, LLC. The 510(k) number is K180377.
When was Fracture and Correction System approved by the FDA?
Fracture and Correction System received FDA 510(k) clearance on 2018-06-20, under approval number K180377.
What company makes Fracture and Correction System?
Fracture and Correction System is manufactured by In2bones USA, LLC.
What is the FDA product code for Fracture and Correction System?
The FDA product code for Fracture and Correction 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.