Cleared Traditional

K003733 - SCS CLOSED SCREW

K003733 is an FDA 510(k) clearance for SCS CLOSED SCREW, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K003733 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
176d
Days
Class 2
Risk

K003733 is an FDA 510(k) clearance for the SCS CLOSED SCREW. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Ortho Tec, LLC (Beverly Hills, US). The FDA issued a Cleared decision on May 29, 2001 after a review of 176 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 Ortho Tec, LLC devices

FDA 510(k) Submission Details - K003733

510(k) Number K003733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date May 29, 2001
Days to Decision 176 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
54d slower than avg
Panel avg: 122d · This submission: 176d
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 180
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K003733.
MOSS MIAMI SPINAL SYSTEMS
K013296 · Depuyacromed · Oct 2001
ISOLA SPINAL SYSTEMS
K012971 · Depuyacromed · Oct 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · United States Surgical, A Division of Tyco Healthc · Aug 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · Depuyacromed · May 2001
CLARIS PLATE SYSTEM
K010369 · Ortho Tec, LLC · May 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845 · Howmedica Osteonics Corp. · Apr 2001