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FDA 510(k)

REXIOUS SPINAL FIXATION SYSTEM

K-Number: K111362 · 2011-07-21

ApplicantDio Medical Co., Ltd.
Decision Date2011-07-21
Product CodeMNH
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 Co., Ltd.. It received FDA 510(k) clearance on 2011-07-21 under 510(k) number K111362. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. 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 2011-07-21. The listed applicant is Dio Medical Co., Ltd.. The 510(k) number is K111362.

When did REXIOUS SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

REXIOUS SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2011-07-21, under 510(k) number K111362.

Who is the listed applicant for REXIOUS SPINAL FIXATION SYSTEM?

The FDA 510(k) record lists Dio Medical Co., Ltd. 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 MNH. This falls under the ENT category.

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Other records listing Dio Medical Co., Ltd. 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.

K162849Huvex Interspinous Fixation SystemK162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageK122872INTERVERTEBRAL BODY FUSION DEVICEK121862REX ANTERIOR CERVICAL PLATE SYSTEMK113324REXIOUS HOOK FIXATION SYSTEMSK100765FIXPINE II SYSTEM

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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