Cleared Special

K143488 - InFill Graft Delivery System (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K143488 · Pinnacle Spine Group, LLC · General Hospital
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Dec 2014
Decision
9d
Days
Class 2
Risk

K143488 is an FDA 510(k) clearance for the InFill Graft Delivery System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Pinnacle Spine Group, LLC (Dallas, US). The FDA issued a Cleared decision on December 17, 2014 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pinnacle Spine Group, LLC devices

Submission Details

510(k) Number K143488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2014
Decision Date December 17, 2014
Days to Decision 9 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 128d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

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All 748
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