DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED— 510(k) K950010

Name: FDA 510(k) clearance K950010
Creator: U.S. Food and Drug Administration
Published: 1995-05-15

Substantially Equivalent for Some Indications

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K950010 for DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED, Substantially Equivalent for Some Indications on 1995-05-15. Applicant: Johnson & Johnson Professionals, Inc.. Device class: 2.

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1995-01-03
Decision date: 1995-05-15
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.