COFIED MODULAR SHOULDER SYSTEM— 510(k) K955767

Name: FDA 510(k) clearance K955767
Creator: U.S. Food and Drug Administration
Published: 1996-04-08

Substantially Equivalent for Some Indications

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K955767 for COFIED MODULAR SHOULDER SYSTEM, Substantially Equivalent for Some Indications on 1996-04-08. Applicant: Smith & Nephew Richards, Inc.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Richards, Inc.
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 1995-12-21
Decision date: 1996-04-08
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K964163 — TRIMAX NAIL SYSTEM1996-12-27
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Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.