Cleared Traditional

K080673 - INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE

K080673 is an FDA 510(k) clearance for INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE, manufactured by Vertebral Technologies, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K080673 · Vertebral Technologies, Inc. · Orthopedic device
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Jun 2008
Decision
92d
Days
Class 2
Risk

K080673 is an FDA 510(k) clearance for the INTERFUSE 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 Vertebral Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on June 10, 2008 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Vertebral Technologies, Inc. devices

FDA 510(k) Submission Details - K080673

510(k) Number K080673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date June 10, 2008
Days to Decision 92 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 670
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K080673.
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K080411 · Life Spine · May 2008
PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM
K073177 · Pioneer Surgical Technology · May 2008
SPINAL USA INTERBODY FUSION DEVICE
K080314 · Spinal USA · May 2008