FDA 510(k)

BF+ (PH)

K-Number: K061462 · 2006-12-15

Decision Date2006-12-15

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BF+ (PH) 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 2006-12-15 under 510(k) number K061462. 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+ (PH)?

BF+ (PH) is a medical device that received FDA 510(k) clearance on 2006-12-15. The listed applicant is Ldr Spine USA. The 510(k) number is K061462.

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

BF+ (PH) received FDA 510(k) clearance on 2006-12-15, under 510(k) number K061462.

Who is the listed applicant for BF+ (PH)?

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+ (PH)?

The FDA product code for BF+ (PH) is MQV.

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 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: MQV)

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.