MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION— 510(k) K031449

Substantially Equivalent

Implex Corp.

FDA 510(k) clearance K031449 for MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, Substantially Equivalent on 2003-09-23. Applicant: Implex Corp..

Clearance details

Applicant: Implex Corp.
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2003-05-07
Decision date: 2003-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.