Cleared Traditional

K020356 - ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM

K020356 is an FDA 510(k) clearance for ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM, manufactured by Alphatec Mfg., Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K020356 · Alphatec Mfg., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
169d
Days
Class 2
Risk

K020356 is an FDA 510(k) clearance for the ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 23, 2002 after a review of 169 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 Alphatec Mfg., Inc. devices

FDA 510(k) Submission Details - K020356

510(k) Number K020356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2002
Decision Date July 23, 2002
Days to Decision 169 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 122d · This submission: 169d
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 179
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K020356.
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · Depuyacromed · Nov 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204 · Ebi, L.P. · Oct 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881 · Endius, Inc. · Jul 2002
COLORADO 2 SPINAL SYSTEM
K020247 · Medtronic Sofamor Danek, Inc. · Jul 2002
MONARCH SPINE SYSTEM
K021335 · Depuyacromed · Jul 2002
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
K021879 · Depuyacromed · Jun 2002