Cleared Traditional

K033352 - VERTEBRON PSS PEDICLE SCREW SYSTEM

K033352 is an FDA 510(k) clearance for VERTEBRON PSS PEDICLE SCREW SYSTEM, manufactured by Vertebron, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K033352 · Vertebron, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
128d
Days
Class 2
Risk

K033352 is an FDA 510(k) clearance for the VERTEBRON PSS PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Vertebron, Inc. (Stratford, US). The FDA issued a Cleared decision on February 25, 2004 after a review of 128 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 Vertebron, Inc. devices

FDA 510(k) Submission Details - K033352

510(k) Number K033352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2003
Decision Date February 25, 2004
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 206
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K033352.
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MODIFICATION TO: CD HORIZON SPINAL SYSTEM
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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