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FDA 510(k)

Rexious Spinal Fixation System

K-Number: K222415 · 2022-10-25

ApplicantDio Medical Corporation
Decision Date2022-10-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Rexious Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical Corporation. It received FDA 510(k) clearance on 2022-10-25 under 510(k) number K222415. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rexious Spinal Fixation System?

Rexious Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-10-25. The listed applicant is Dio Medical Corporation. The 510(k) number is K222415.

When did Rexious Spinal Fixation System receive FDA 510(k) clearance?

Rexious Spinal Fixation System received FDA 510(k) clearance on 2022-10-25, under 510(k) number K222415.

Who is the listed applicant for Rexious Spinal Fixation System?

The FDA 510(k) record lists Dio Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rexious Spinal Fixation System?

The FDA product code for Rexious Spinal Fixation System is NKB.

Other records listing Dio Medical Corporation 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.

K223790Huvex Interspinous Fusion SystemK223140AEON-C™ Stand Alone SystemK222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate SystemK222448UNITY Sacroiliac Joint Fixation SystemK222515FaSet Fixation SystemK162849Huvex Interspinous Fixation System

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Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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.

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