Cleared Traditional

K962628 - MOSS MIAMI SPINAL SYSTEM

K962628 is an FDA 510(k) clearance for MOSS MIAMI SPINAL SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K962628 · Depuy, Inc. · Orthopedic device
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Mar 1997
Decision
256d
Days
Class 2
Risk

K962628 is an FDA 510(k) clearance for the MOSS MIAMI SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 256 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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, Inc. devices

FDA 510(k) Submission Details - K962628

510(k) Number K962628 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 05, 1996
Decision Date March 18, 1997
Days to Decision 256 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 122d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 385
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K962628.
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
K964254 · Sofamor Danek USA,Inc. · Apr 1997
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024 · Depuy, Inc. · Mar 1997
BACFIX SPINAL FIXATION SYSTEM
K964404 · Spinal Concepts, Inc. · Mar 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · Depuy, Inc. · Mar 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708 · Sofamor Danek USA,Inc. · Feb 1997
FINN ROD TO ROD CONNECTOR
K960444 · Smith & Nephew Richards, Inc. · Jan 1997