Cleared Special

K062505 - NEX-LINK SPINAL FIXATION SYSTEM OFFSET ...

K062505 is the FDA 510(k) clearance for NEX-LINK SPINAL FIXATION SYSTEM OFFSET ... by Abbott Spine, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 29-day FDA review.

K062505 · Abbott Spine, Inc. · Orthopedic device
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Sep 2006
Decision
29d
Days
Class 2
Risk

K062505 is an FDA 510(k) clearance for the NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Abbott Spine, Inc. (Austin, US). The FDA issued a Cleared decision on September 26, 2006 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Abbott Spine, Inc. devices

Submission Details

510(k) Number K062505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2006
Decision Date September 26, 2006
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 148
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K062505.
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062879 · Medtronic Sofamor Danek, Inc. · Dec 2006
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K062853 · Stryker Spine · Oct 2006
TRIO + SPINAL SYSTEM
K062698 · Stryker Spine · Oct 2006
CD HORIZON SPINAL SYSTEM
K062606 · Medtronic Sofamor Danek · Sep 2006
ARX SPINAL SYSTEM
K061600 · Life Spine · Aug 2006
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
K061978 · Ebi, L.P. · Aug 2006