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)
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.

View all Ortho Tec, LLC devices

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 180
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K994288.
PASS SPINAL SYSTEM
K001024 · Encore Orthopedics, Inc. · May 2000
XIA SPINE SYSTEM HOOKS
K001319 · Howmedica Osteonics Corp. · May 2000
COLORADO II SPINAL SYSTEM
K991031 · Sofamor Danek USA,Inc. · May 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