Cleared Traditional

K092011 - NORM SPINAL SYSTEM

K092011 is an FDA 510(k) clearance for NORM SPINAL SYSTEM, manufactured by Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K092011 · Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
114d
Days
Class 2
Risk

K092011 is an FDA 510(k) clearance for the NORM SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar (Ankara, TR). The FDA issued a Cleared decision on October 28, 2009 after a review of 114 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. 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 Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar devices

FDA 510(k) Submission Details - K092011

510(k) Number K092011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date October 28, 2009
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
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 201
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K092011.
MIS SYSTEM
K100605 · Spine Wave, Inc. · Jun 2010
MODIFICATION TO: OASYS SYSTEM
K093670 · Stryker Spine · Mar 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · Spine Wave, Inc. · Feb 2010
FORTEX PEDICLE SCREW SYSTEM
K090224 · X-Spine Systems, Inc. · Jul 2009
ROC LUMBAR PLATING SYSTEM
K090228 · Alphatec Spine, Inc. · Apr 2009
LANX SPINAL FIXATION SYSTEM
K083581 · Lanx, Inc. · Apr 2009