FDA 510(k)

MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM

K-Number: K090507 · 2009-06-25

Decision Date2009-06-25

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA. It received FDA 510(k) clearance on 2009-06-25 under 510(k) number K090507. 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 MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM?

MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-25. The listed applicant is Ldr Spine USA. The 510(k) number is K090507.

When did MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM received FDA 510(k) clearance on 2009-06-25, under 510(k) number K090507.

Who is the listed applicant for MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM?

The FDA 510(k) record lists Ldr Spine USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM?

The FDA product code for MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM is MAX.

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Other records listing Ldr Spine USA as applicant

K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System K152137FacetBRIDGE System K110327LDR SPINE ROI-A INTERBODY FUSION SYSTEM K102331LDR SPINE USA SPINETUNE TL SPINAL SYSTEM K102265LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM K100575LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

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Related Devices (Code: MAX)

K261049SCALA® TLSpineart SA K261430TruLift 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 Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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.