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FDA 510(k)

LDR SPINE USA SPINETUNE TL SPINAL SYSTEM

K-Number: K102331 · 2010-10-15

ApplicantLdr Spine USA
Decision Date2010-10-15
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LDR SPINE USA SPINETUNE TL SPINAL 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 2010-10-15 under 510(k) number K102331. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDR SPINE USA SPINETUNE TL SPINAL SYSTEM?

LDR SPINE USA SPINETUNE TL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-15. The listed applicant is Ldr Spine USA. The 510(k) number is K102331.

When did LDR SPINE USA SPINETUNE TL SPINAL SYSTEM receive FDA 510(k) clearance?

LDR SPINE USA SPINETUNE TL SPINAL SYSTEM received FDA 510(k) clearance on 2010-10-15, under 510(k) number K102331.

Who is the listed applicant for LDR SPINE USA SPINETUNE TL SPINAL 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 USA SPINETUNE TL SPINAL SYSTEM?

The FDA product code for LDR SPINE USA SPINETUNE TL SPINAL SYSTEM is MNI.

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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 SystemK110327LDR SPINE ROI-A INTERBODY FUSION 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: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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