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FDA 510(k)

INTERVERTEBRAL BODY FUSION DEVICE

K-Number: K122872 · 2013-02-28

ApplicantDio Medical Co., Ltd.
Decision Date2013-02-28
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERVERTEBRAL BODY FUSION DEVICE 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 2013-02-28 under 510(k) number K122872. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERVERTEBRAL BODY FUSION DEVICE?

INTERVERTEBRAL BODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2013-02-28. The listed applicant is Dio Medical Co., Ltd.. The 510(k) number is K122872.

When did INTERVERTEBRAL BODY FUSION DEVICE receive FDA 510(k) clearance?

INTERVERTEBRAL BODY FUSION DEVICE received FDA 510(k) clearance on 2013-02-28, under 510(k) number K122872.

Who is the listed applicant for INTERVERTEBRAL BODY FUSION DEVICE?

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 INTERVERTEBRAL BODY FUSION DEVICE?

The FDA product code for INTERVERTEBRAL BODY FUSION DEVICE is ODP.

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Related PubMed Literature

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.

PMID: 33778409Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices.JOR spine ()PMID: 28256243Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.Journal of biomechanics ()

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) CageK121862REX ANTERIOR CERVICAL PLATE SYSTEMK113324REXIOUS HOOK FIXATION SYSTEMSK111362REXIOUS SPINAL FIXATION SYSTEMK100765FIXPINE II SYSTEM

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Related Devices (Code: ODP)

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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED 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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