Cleared Traditional

K013301 - UNI-T SPINAL SYSTEM

K013301 is an FDA 510(k) clearance for UNI-T SPINAL SYSTEM, manufactured by Spine Vision, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K013301 · Spine Vision, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2002
Decision
133d
Days
Class 2
Risk

K013301 is an FDA 510(k) clearance for the UNI-T SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spine Vision, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 13, 2002 after a review of 133 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K013301

510(k) Number K013301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2001
Decision Date February 13, 2002
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K013301.
SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K021379 · Ortho Tec, LLC · May 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K021106 · Medtronic Sofamor Danek, Inc. · May 2002
SYNTHES DUAL-OPENING USS
K020517 · Synthes (Usa) · Apr 2002
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
K013885 · Blackstone Medical, Inc. · Feb 2002
PASS SPINAL SYSTEM
K013431 · Encore Orthopedics, Inc. · Nov 2001
TRI-FIX SPINAL FIXATION SYSTEM
K013403 · Endius, Inc. · Nov 2001