Cleared Traditional

K063453 - VERTEFIX PEDICLE SCREW SPINAL SYSTEM

K063453 is an FDA 510(k) clearance for VERTEFIX PEDICLE SCREW SPINAL SYSTEM, manufactured by Elite Surgical Supplies (Pty), Ltd.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K063453

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.

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 242
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K063453.
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NUVASIVE OCT SYSTEM
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SYNAPSE SYSTEM
K070573 · Synthes Spine Co.Lp · Jun 2007