Cleared Traditional

K954645 - TITANIUM GDLH POSTERIOR SPINAL SYSTEM

K954645 is an FDA 510(k) clearance for TITANIUM GDLH POSTERIOR SPINAL SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K954645 · Sofamor Danek USA,Inc. · Orthopedic device
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Jan 1996
Decision
98d
Days
Class 2
Risk

K954645 is an FDA 510(k) clearance for the TITANIUM GDLH POSTERIOR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on January 16, 1996 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K954645

510(k) Number K954645 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 10, 1995
Decision Date January 16, 1996
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K954645.
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348 · Depuy, Inc. · Feb 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164 · Sofamor Danek USA,Inc. · Feb 1996
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K955173 · Osteotech, Inc. · Feb 1996
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
K936294 · Sofamor Danek Mfg., Inc. · Dec 1995
WEBB-MORLEY SPINE SYSTEM
K945781 · Electro-Biology, Inc. · Jun 1995
STRYKER 2S SPINAL SYSTEM
K930009 · Stryker Corp. · Sep 1994