ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM— 510(k) K935593

Substantially Equivalent

Biodynamic Technologies, Inc.

FDA 510(k) clearance K935593 for ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM, Substantially Equivalent on 1994-10-14. Applicant: Biodynamic Technologies, Inc..

Clearance details

Applicant: Biodynamic Technologies, Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 1993-11-19
Decision date: 1994-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, 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.