BDH UNIVERSAL HIP SYSTEM SURGEON— 510(k) K833468

Substantially Equivalent

Carbomedics, Inc.

FDA 510(k) clearance K833468 for BDH UNIVERSAL HIP SYSTEM SURGEON, Substantially Equivalent on 1983-12-27. Applicant: Carbomedics, Inc..

Clearance details

Applicant: Carbomedics, Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1983-10-06
Decision date: 1983-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.