DeviceClearance

COLUMBUS TOTAL KNEE SYSTEM (CR)— 510(k) K022672

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K022672 for COLUMBUS TOTAL KNEE SYSTEM (CR), Substantially Equivalent on 2002-11-08. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant
Aesculap, Inc.
Product code
Code JWH
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Center Valley, PA, US
Download summary PDFView 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, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K022672

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022672.

Data sourced from openFDA. This site is unofficial and independent of the FDA.