Cleared Traditional

K953635 - TITANIUM DYNA-LOK SPINAL SYSTEM

K953635 is an FDA 510(k) clearance for TITANIUM DYNA-LOK SPINAL SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K953635 · Sofamor Danek USA,Inc. · Orthopedic device
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Oct 1995
Decision
89d
Days
Class 2
Risk

K953635 is an FDA 510(k) clearance for the TITANIUM DYNA-LOK SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Winona Lake, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 89 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K953635

510(k) Number K953635 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 02, 1995
Decision Date October 30, 1995
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K953635.
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717 · Sofamor Danek USA,Inc. · Feb 1996
KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
K950999 · Buckman Co., Inc. · Jan 1996
ISOLA SYSTEM
K952236 · Acromed Corp. · Jan 1996
OSTEONICS SPINAL SYSTEM
K951725 · Osteonics Corp. · Sep 1995
ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT
K950865 · Smith & Nephew Richards, Inc. · Sep 1995
GDLH POSTERIOR SPINAL SYSTEM
K950596 · Sofamor Danek USA,Inc. · Aug 1995