EMPOWER ANTERIOR DIRECT SCREWS— 510(k) K965224

Substantially Equivalent

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K965224 for EMPOWER ANTERIOR DIRECT SCREWS, Substantially Equivalent on 1997-05-08. Applicant: Smith & Nephew Richards, Inc..

Clearance details

Applicant: Smith & Nephew Richards, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1996-12-30
Decision date: 1997-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.