Cleared Traditional

K951846 - MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYL...

K951846 is an FDA 510(k) clearance for MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYL..., manufactured by Alphatec Mfg., Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K951846 · Alphatec Mfg., Inc. · Orthopedic device
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Feb 1996
Decision
300d
Days
Class 2
Risk

K951846 is an FDA 510(k) clearance for the MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Concord, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Alphatec Mfg., Inc. devices

FDA 510(k) Submission Details - K951846

510(k) Number K951846 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 20, 1995
Decision Date February 14, 1996
Days to Decision 300 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
178d slower than avg
Panel avg: 122d · This submission: 300d
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 335
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K951846.
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365 · Sofamor Danek USA,Inc. · Mar 1996
ROGOZINSKI THORACOLUMBAR SPINAL ROD
K954696 · Smith & Nephew Richards, Inc. · Mar 1996
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
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645 · Sofamor Danek USA,Inc. · Jan 1996