AML CALCAR FEMORAL PROSTHESIS— 510(k) K874100

Name: FDA 510(k) clearance K874100
Creator: U.S. Food and Drug Administration
Published: 1987-12-31

Substantially Equivalent for Some Indications

Depuy, Inc.

FDA 510(k) clearance K874100 for AML CALCAR FEMORAL PROSTHESIS, Substantially Equivalent for Some Indications on 1987-12-31. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1987-10-08
Decision date: 1987-12-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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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.