Cleared Abbreviated

K092815 - S-LIF INTERVERTEBRAL BODY FUSION DEVICE

K092815 is an FDA 510(k) clearance for S-LIF INTERVERTEBRAL BODY FUSION DEVICE, manufactured by Spinefrontier, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Abbreviated 510(k) pathway after a 289-day FDA review.

K092815 · Spinefrontier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
289d
Days
Class 2
Risk

K092815 is an FDA 510(k) clearance for the S-LIF INTERVERTEBRAL BODY FUSION DEVICE. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Spinefrontier, Inc. (Beverly, US). The FDA issued a Cleared decision on June 30, 2010 after a review of 289 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Spinefrontier, Inc. devices

FDA 510(k) Submission Details - K092815

510(k) Number K092815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date June 30, 2010
Days to Decision 289 days
Submission Type Abbreviated
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
167d slower than avg
Panel avg: 122d · This submission: 289d
Pathway characteristics
Standards-based clearance path.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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.

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All 797
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