Cleared Special

K102277 - INTERFUSE T INVERTEBRAL BODY FUSION DEVICE

K102277 is an FDA 510(k) clearance for INTERFUSE T INVERTEBRAL BODY FUSION DEVICE, manufactured by Vertebral Technologies, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 56-day FDA review.

K102277 · Vertebral Technologies, Inc. · Orthopedic device
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Oct 2010
Decision
56d
Days
Class 2
Risk

K102277 is an FDA 510(k) clearance for the INTERFUSE T INVERTEBRAL 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. (Minneapolis, US). The FDA issued a Cleared decision on October 6, 2010 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. 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 Vertebral Technologies, Inc. devices

FDA 510(k) Submission Details - K102277

510(k) Number K102277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2010
Decision Date October 06, 2010
Days to Decision 56 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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
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