Cleared Traditional

K962784 - ULTIUM SPINAL PLATING SYSTEM

K962784 is an FDA 510(k) clearance for ULTIUM SPINAL PLATING SYSTEM, manufactured by Smith & Nephew, Inc., Orthopaedic Div.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K962784 · Smith & Nephew, Inc., Orthopaedic Div. · Orthopedic device
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Oct 1996
Decision
77d
Days
Class 2
Risk

K962784 is an FDA 510(k) clearance for the ULTIUM SPINAL PLATING SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc., Orthopaedic Div. (Memphis, US). The FDA issued a Cleared decision on October 2, 1996 after a review of 77 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 Smith & Nephew, Inc., Orthopaedic Div. devices

FDA 510(k) Submission Details - K962784

510(k) Number K962784 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 17, 1996
Decision Date October 02, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
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 173
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K962784.
ACROMED CABLE/WIRE PEDICLE SCREW
K964007 · Acromed Corp. · Dec 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · Synthes (Usa) · Dec 1996
ISOLA TWISTER CONNECTOR
K962645 · Acromed Corp. · Oct 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572 · Wrightmedicaltechnologyinc · Sep 1996
DDS SPINAL SYSTEM
K960107 · Encore Orthopedics, Inc. · May 1996
WEBB-MORLEY SPINE SYSTEM
K960451 · Buckman Co., Inc. · Apr 1996