Cleared Traditional

K980852 - GII SPINAL FIXATION SYSTEM

K980852 is an FDA 510(k) clearance for GII SPINAL FIXATION SYSTEM, manufactured by Karen E. Warden, M.E.B.E.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K980852 · Karen E. Warden, M.E.B.E. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
57d
Days
Class 2
Risk

K980852 is an FDA 510(k) clearance for the GII SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Karen E. Warden, M.E.B.E. (Cleveland, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Karen E. Warden, M.E.B.E. devices

FDA 510(k) Submission Details - K980852

510(k) Number K980852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1998
Decision Date May 01, 1998
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
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 253
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K980852.
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM
K981714 · Acromed Corp. · Jun 1998
PEDIATRIC PRC
K981113 · Acromed Corp. · May 1998
TITANIUM SPINAL ROD SYSTEM
K980862 · United States Surgical, A Division of Tyco Healthc · May 1998
ACROMED TIMX PLATE BASED LOW BACK SYSTEM
K981274 · Acromed Corp. · Apr 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447 · DePuy Orthopaedics, Inc. · Apr 1998
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496 · Wrightmedicaltechnologyinc · Apr 1998