Cleared Special

K994288 - 5.0MM SPINAL SCREWS

K994288 is an FDA 510(k) clearance for 5.0MM SPINAL SCREWS, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 112-day FDA review.

K994288 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
112d
Days
Class 2
Risk

K994288 is an FDA 510(k) clearance for the 5.0MM SPINAL SCREWS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Ortho Tec, LLC (Pleasant Hill, US). The FDA issued a Cleared decision on April 10, 2000 after a review of 112 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 - K994288

510(k) Number K994288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1999
Decision Date April 10, 2000
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 K994288.
XIA SPINE SYSTEM HOOKS
K001319 · Howmedica Osteonics Corp. · May 2000
COLORADO II SPINAL SYSTEM
K991031 · Sofamor Danek USA,Inc. · May 2000
HAIDER-UCR SPINAL SYSTEM
K993503 · International Advanced Medical Enterprises, Inc. · Apr 2000
COLORADO II SPINAL SYSTEM
K984360 · Sofamor Danek USA,Inc. · Mar 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453 · Medtronic Sofamor Danek, Inc. · Mar 2000
MODIFICATION TO CD SPINAL SYSTEM
K000476 · Medtronic Sofamor Danek, Inc. · Mar 2000
K994288 · 5.0MM SPINAL SCREWS
Download PDF FDA Summary Ortho Tec, LLC