Cleared Special

K061462 - BF+ (PH)

K061462 is an FDA 510(k) clearance for BF+ (PH), manufactured by Ldr Spine USA. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 203-day FDA review.

K061462 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
203d
Days
Class 2
Risk

K061462 is an FDA 510(k) clearance for the BF+ (PH). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ldr Spine USA (Austin, US). The FDA issued a Cleared decision on December 15, 2006 after a review of 203 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ldr Spine USA devices

FDA 510(k) Submission Details - K061462

510(k) Number K061462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2006
Decision Date December 15, 2006
Days to Decision 203 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
Pathway characteristics
Modification to existing cleared device.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 290
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K061462.
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ALLOGRAN-R
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