TEMA Elbow system - Line extension— 510(k) K222807

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K222807 for TEMA Elbow system - Line extension, Substantially Equivalent on 2022-10-26. Applicant: Lima Corporate S.P.A..

Clearance details

Applicant: Lima Corporate S.P.A.
Product code: Code JDB
Advisory panel: Orthopedic
Date received: 2022-09-16
Decision date: 2022-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villanova Di San Daniele Del Friuli, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

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.