BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1— 510(k) K012702

Substantially Equivalent

Endotec, Inc.

FDA 510(k) clearance K012702 for BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1, Substantially Equivalent on 2002-01-30. Applicant: Endotec, Inc..

Clearance details

Applicant: Endotec, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2001-08-14
Decision date: 2002-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Orange, NJ, US

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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.