Cleared Traditional

K973425 - THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW ...

K973425 is an FDA 510(k) clearance for THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW ..., manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K973425 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
170d
Days
Class 2
Risk

K973425 is an FDA 510(k) clearance for the THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on February 27, 1998 after a review of 170 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 Corin USA devices

FDA 510(k) Submission Details - K973425

510(k) Number K973425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1997
Decision Date February 27, 1998
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
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 172
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K973425.
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496 · Wrightmedicaltechnologyinc · Apr 1998
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
K973687 · Spinal Concepts, Inc. · Mar 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · United States Surgical, A Division of Tyco Healthc · Mar 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974213 · United States Surgical, A Division of Tyco Healthc · Feb 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568 · Depuy, Inc. · Sep 1997
EBI SPINELINK SYSTEM
K971970 · Electro-Biology, Inc. · Aug 1997