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FDA 510(k)

LDR SPINE SPINETUNE TL SPINAL SYSTEM

K-Number: K120760 · 2012-06-27

ApplicantLdr Spine USA, Inc.
Decision Date2012-06-27
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LDR SPINE SPINETUNE TL SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2012-06-27 under 510(k) number K120760. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDR SPINE SPINETUNE TL SPINAL SYSTEM?

LDR SPINE SPINETUNE TL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-06-27. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K120760.

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

LDR SPINE SPINETUNE TL SPINAL SYSTEM received FDA 510(k) clearance on 2012-06-27, under 510(k) number K120760.

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

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

What is the FDA product code for LDR SPINE SPINETUNE TL SPINAL SYSTEM?

The FDA product code for LDR SPINE SPINETUNE TL SPINAL SYSTEM is MNH. This falls under the ENT category.

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Other records listing Ldr Spine USA, Inc. 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.

K162133VerteFIT Corpectomy Cage SystemK161173Avenue® T TLIF CageK161798FacetBRIDGE® SystemK123134EASYSPINE SYSTEMK121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT SK113285LDR SPINE USA AVENUE L INTERBODY FUSION

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Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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