ULTIUM SPINAL PLATING SYSTEM— 510(k) K962784

Name: FDA 510(k) clearance K962784
Creator: U.S. Food and Drug Administration
Published: 1996-10-02

Substantially Equivalent for Some Indications

Smith & Nephew, Inc., Orthopaedic Div.

FDA 510(k) clearance K962784 for ULTIUM SPINAL PLATING SYSTEM, Substantially Equivalent for Some Indications on 1996-10-02. Applicant: Smith & Nephew, Inc., Orthopaedic Div.. Device class: 2.

Clearance details

Applicant: Smith & Nephew, Inc., Orthopaedic Div.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1996-07-17
Decision date: 1996-10-02
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.