DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS— 510(k) K112898

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K112898 for DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS, Substantially Equivalent on 2012-12-21. Applicant: Lima Corporate S.P.A..

Clearance details

Applicant: Lima Corporate S.P.A.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 2011-10-03
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona Lake, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.