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FDA 510(k)

BF+

K-Number: K043347 · 2005-01-07

ApplicantLdr Spine USA
Decision Date2005-01-07
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BF+ 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 2005-01-07 under 510(k) number K043347. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BF+?

BF+ is a medical device that received FDA 510(k) clearance on 2005-01-07. The listed applicant is Ldr Spine USA. The 510(k) number is K043347.

When did BF+ receive FDA 510(k) clearance?

BF+ received FDA 510(k) clearance on 2005-01-07, under 510(k) number K043347.

Who is the listed applicant for BF+?

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 BF+?

The FDA product code for BF+ is MQV.

Other records listing Ldr Spine USA as applicant

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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 SYSTEMK102331LDR SPINE USA SPINETUNE TL SPINAL SYSTEMK102265LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEMK100575LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

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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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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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