SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS— 510(k) K962224

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K962224 for SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS, Substantially Equivalent on 1996-08-28. Applicant: Intermedics Orthopedics.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 1996-06-10
Decision date: 1996-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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.