INFINITY SHOULDER SYSTEM— 510(k) K943908

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K943908 for INFINITY SHOULDER SYSTEM, Substantially Equivalent on 1995-05-30. Applicant: Wrightmedicaltechnologyinc.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 1994-08-11
Decision date: 1995-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

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Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.