Cleared Traditional

K033508 - PLUS PIVOT LINK UNIVERSAL SYSTEM

K033508 is an FDA 510(k) clearance for PLUS PIVOT LINK UNIVERSAL 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 82-day FDA review.

K033508 · Spine Vision, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
82d
Days
Class 2
Risk

K033508 is an FDA 510(k) clearance for the PLUS PIVOT LINK UNIVERSAL 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 January 27, 2004 after a review of 82 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 - K033508

510(k) Number K033508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2003
Decision Date January 27, 2004
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 217
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K033508.
MODIFICATION TO ORIA TOP CLIP SYSTEM
K040346 · Ortho Tec, LLC · Mar 2004
STRYKER SPINE OASYS SYSTEM
K032394 · Howmedica Osteonics Corp. · Feb 2004
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034 · Blackstone Medical, Inc. · Feb 2004
POSTERIOR CABLE SCREW
K022908 · Pioneer Surgical Technology · Jan 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · Medtronic Sofamor Danek, Inc. · Dec 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · Ortho Tec, LLC · Nov 2003