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FDA 510(k)

LDR SPINE ROI-A INTERBODY FUSION SYSTEM

K-Number: K110327 · 2011-09-30

ApplicantLdr Spine USA
Decision Date2011-09-30
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LDR SPINE ROI-A INTERBODY FUSION 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 2011-09-30 under 510(k) number K110327. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDR SPINE ROI-A INTERBODY FUSION SYSTEM?

LDR SPINE ROI-A INTERBODY FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Ldr Spine USA. The 510(k) number is K110327.

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

LDR SPINE ROI-A INTERBODY FUSION SYSTEM received FDA 510(k) clearance on 2011-09-30, under 510(k) number K110327.

Who is the listed applicant for LDR SPINE ROI-A INTERBODY FUSION 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 LDR SPINE ROI-A INTERBODY FUSION SYSTEM?

The FDA product code for LDR SPINE ROI-A INTERBODY FUSION SYSTEM is OVD.

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Other records listing Ldr Spine USA 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.

K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemK152137FacetBRIDGE SystemK102331LDR SPINE USA SPINETUNE TL SPINAL SYSTEMK102265LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEMK100575LDR SPINE USA SPINE TUNE TL SPINE SYSTEMK091088LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

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Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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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