FDA 510(k)

REDEMPTION Beaming System

K-Number: K221342 · 2022-12-13

Decision Date2022-12-13

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REDEMPTION Beaming System is the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2022-12-13 under 510(k) number K221342. 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 REDEMPTION Beaming System?

REDEMPTION Beaming System is a medical device that received FDA 510(k) clearance on 2022-12-13. The listed applicant is Vilex, LLC. The 510(k) number is K221342.

When did REDEMPTION Beaming System receive FDA 510(k) clearance?

REDEMPTION Beaming System received FDA 510(k) clearance on 2022-12-13, under 510(k) number K221342.

Who is the listed applicant for REDEMPTION Beaming System?

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

What is the FDA product code for REDEMPTION Beaming System?

The FDA product code for REDEMPTION Beaming System is HWC. This falls under the Cardiovascular category.

Other records listing Vilex, 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.

K260900DYNEX® External Fixation Systems K250304TITANEX Screw Systems K240475Hintermann Series H2 Total Ankle System K243408TACTIX Vector Syndesmosis System K233816REDEMPTION Charcot Plating System K240035TACTIX Vector Syndesmosis System

View all 17 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.