Cleared Traditional

K953369 - STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW

K953369 is an FDA 510(k) clearance for STAINLESS STEEL VARIFIX SYSTEM 5.0MM DI..., manufactured by Advanced Spine Fixation Systems, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K953369 · Advanced Spine Fixation Systems, Inc. · Orthopedic device
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Sep 1995
Decision
52d
Days
Class 2
Risk

K953369 is an FDA 510(k) clearance for the STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Advanced Spine Fixation Systems, Inc. (Cypress, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 52 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 Advanced Spine Fixation Systems, Inc. devices

FDA 510(k) Submission Details - K953369

510(k) Number K953369 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 18, 1995
Decision Date September 08, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 208
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K953369.
SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
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GDLH POSTERIOR SPINAL SYSTEM
K950596 · Sofamor Danek USA,Inc. · Aug 1995
PARAGON POSTERIOR SPINAL SYSTEM
K950955 · Sofamor Danek USA,Inc. · Aug 1995