FDA 510(k)

Fracture and Correction System

K-Number: K180377 · 2018-06-20

Decision Date2018-06-20

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Fracture and Correction System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2018-06-20 under 510(k) 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. The listed applicant is In2bones USA, LLC. The 510(k) number is K180377.

When did Fracture and Correction System receive FDA 510(k) clearance?

Fracture and Correction System received FDA 510(k) clearance on 2018-06-20, under 510(k) number K180377.

Who is the listed applicant for Fracture and Correction System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing In2bones USA, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261154CoLink® & CoLag® Non-Sterile Screws K241387CoLink NeoFuse MIS Plating System (see attached parts list)K233089NeoSpan® Compression Implant System K231236IBS-B MIS Beveled Screw System K213698CoLink PCR Plating System K220260Hercules Syndesmosis Implant System

View all 27 devices →

Related Devices (Code: HWC)

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLC K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps Ortho K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, 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.