Cleared Traditional

K063453 - VERTEFIX PEDICLE SCREW SPINAL SYSTEM

K063453 is the FDA 510(k) clearance for VERTEFIX PEDICLE SCREW SPINAL SYSTEM by Elite Surgical Supplies (Pty), Ltd.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K063453 · Elite Surgical Supplies (Pty), Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
288d
Days
Class 2
Risk

K063453 is an FDA 510(k) clearance for the VERTEFIX PEDICLE SCREW SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Elite Surgical Supplies (Pty), Ltd. (Marietta, US). The FDA issued a Cleared decision on August 30, 2007 after a review of 288 days - an extended review 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: 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 Elite Surgical Supplies (Pty), Ltd. devices

Submission Details

510(k) Number K063453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2006
Decision Date August 30, 2007
Days to Decision 288 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
166d slower than avg
Panel avg: 122d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 146
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K063453.
NATURAL BRIDGE LP TRANSVERSE CONNECTORS
K072914 · K2m, Inc. · Jan 2008
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187 · Pioneer Surgical Technology · Oct 2007
Optima ZS Transition Screw
K071880 · Zimmer Spine, Inc. · Oct 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007
ROC LUMBAR SYSTEM
K063668 · Alphatec Spine, Inc. · May 2007
RANGE SPINAL SYSTEM
K070229 · K2m, Inc. · May 2007