SELECT SHOULDER SYSTEM— 510(k) K873679

Substantially Equivalent for Some Indications

Intermedics Orthopedics

FDA 510(k) clearance K873679 for SELECT SHOULDER SYSTEM, Substantially Equivalent for Some Indications on 1987-11-17. Applicant: Intermedics Orthopedics.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 1987-09-14
Decision date: 1987-11-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, 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.