BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD— 510(k) K960424

Name: FDA 510(k) clearance K960424
Creator: U.S. Food and Drug Administration
Published: 1996-08-26

Substantially Equivalent

Endotec, Inc.

FDA 510(k) clearance K960424 for BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD, Substantially Equivalent on 1996-08-26. Applicant: Endotec, Inc.. Device class: 2.

Clearance details

Applicant: Endotec, Inc.
Product code: Code KWT
Device class: Class 2
Regulation: 21 CFR 888.3650
Advisory panel: Orthopedic
Date received: 1996-01-29
Decision date: 1996-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomfield, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.