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FDA 510(k)

DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE

K-Number: K081673 · 2008-11-14

ApplicantIonics Medical Corp.
Decision Date2008-11-14
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ionics Medical Corp.. It received FDA 510(k) clearance on 2008-11-14 under 510(k) number K081673. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE?

DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2008-11-14. The listed applicant is Ionics Medical Corp.. The 510(k) number is K081673.

When did DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE receive FDA 510(k) clearance?

DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE received FDA 510(k) clearance on 2008-11-14, under 510(k) number K081673.

Who is the listed applicant for DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE?

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

What is the FDA product code for DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE?

The FDA product code for DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE is MAX.

Related Clinical Trials

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.

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Other records listing Ionics Medical Corp. 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.

K983667IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE

Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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