Cleared Traditional

K021510 - UNI-T UNI-THREAD SPINAL SYSTEM

K021510 is an FDA 510(k) clearance for UNI-T UNI-THREAD 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 84-day FDA review.

K021510 · Spine Vision, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
84d
Days
Class 2
Risk

K021510 is an FDA 510(k) clearance for the UNI-T UNI-THREAD 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 August 1, 2002 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spine Vision, Inc. devices

FDA 510(k) Submission Details - K021510

510(k) Number K021510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2002
Decision Date August 01, 2002
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 K021510.
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
K023644 · Spinal Concepts, Inc. · Nov 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · Medtronic Sofamor Danek, Inc. · Sep 2002
MODIFICATION TO ISOLA SPINAL SYSTEM
K022285 · Depuyacromed · Aug 2002
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K022190 · Depuyacromed · Jul 2002
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