Cleared Traditional

K950596 - GDLH POSTERIOR SPINAL SYSTEM

K950596 is an FDA 510(k) clearance for GDLH POSTERIOR 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 200-day FDA review.

K950596 · Sofamor Danek USA,Inc. · Orthopedic device
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Aug 1995
Decision
200d
Days
Class 2
Risk

K950596 is an FDA 510(k) clearance for the GDLH POSTERIOR SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 200 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K950596

510(k) Number K950596 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 09, 1995
Decision Date August 28, 1995
Days to Decision 200 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
78d slower than avg
Panel avg: 122d · This submission: 200d
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 K950596.
TITANIUM DYNA-LOK SPINAL SYSTEM
K953635 · Sofamor Danek USA,Inc. · Oct 1995
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
PARAGON POSTERIOR SPINAL SYSTEM
K950955 · Sofamor Danek USA,Inc. · Aug 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
K951626 · Synthes (Usa) · Aug 1995
VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)
K951657 · Acromed Corp. · Aug 1995