SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM— 510(k) K081016

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K081016 for SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM, Substantially Equivalent on 2008-09-05. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2008-04-09
Decision date: 2008-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

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.