Cleared Traditional

K950697 - DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION

K950697 is an FDA 510(k) clearance for DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM -..., manufactured by Depuy Motech. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K950697 · Depuy Motech · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
136d
Days
Class 2
Risk

K950697 is an FDA 510(k) clearance for the DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Depuy Motech (Warsaw, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 136 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 Depuy Motech devices

FDA 510(k) Submission Details - K950697

510(k) Number K950697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date June 22, 1995
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 295
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K950697.
5.8MM DIAMETER ANCHOR SCREW
K951308 · Advanced Spine Fixation Systems, Inc. · Jul 1995
TITANIUM LOW PROFILE CROSS BAR
K951172 · Advanced Spine Fixation Systems, Inc. · Jul 1995
ISOLA SPINE SYSTEM
K944737 · Acromed Corp. · Jun 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353 · Smith & Nephew, Inc. · Jun 1995
ROGOZINSKI SPINAL ROD SYSTEM SCREW
K930298 · Smith & Nephew Richards, Inc. · Jun 1995
ISOLA OPEN AND CLOSED SCREWS
K944756 · Acromed Corp. · May 1995