SELECT SHOULDER COCR HUMERAL STEM COMPONENT— 510(k) K962289

Name: FDA 510(k) clearance K962289
Creator: U.S. Food and Drug Administration
Published: 1996-08-29

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K962289 for SELECT SHOULDER COCR HUMERAL STEM COMPONENT, Substantially Equivalent on 1996-08-29. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code HSD
Device class: Class 2
Regulation: 21 CFR 888.3690
Advisory panel: Orthopedic
Date received: 1996-06-14
Decision date: 1996-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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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.