SMR TT Metal Back Glenoid, Bone Graft instruments— 510(k) K161120

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K161120 for SMR TT Metal Back Glenoid, Bone Graft instruments, Substantially Equivalent on 2017-02-21. Applicant: Lima Corporate S.P.A..

Clearance details

Applicant: Lima Corporate S.P.A.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2016-04-21
Decision date: 2017-02-21
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 PHX

product code PHX

Death: 10
Injury: 9,705
Malfunction: 1,252
Total: 10,967

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.