Cleared Special

K021623 - UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS

K021623 is an FDA 510(k) clearance for UCR SPINAL SYSTEM, manufactured by Iame, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 117-day FDA review.

K021623 · Iame, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
117d
Days
Class 2
Risk

K021623 is an FDA 510(k) clearance for the UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Iame, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on September 10, 2002 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021623

510(k) Number K021623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2002
Decision Date September 10, 2002
Days to Decision 117 days
Submission Type Special
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
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K021623.
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
K020085 · Sintea Biotech, Inc. · Dec 2002
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
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K020356 · Alphatec Mfg., Inc. · Jul 2002
COLORADO 2 SPINAL SYSTEM
K020247 · Medtronic Sofamor Danek, Inc. · Jul 2002
K021623 · UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
Download PDF FDA Summary Iame, Inc.