SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid— 510(k) K213785

Substantially Equivalent

Limacorporate

FDA 510(k) clearance K213785 for SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid, Substantially Equivalent on 2022-05-13. Applicant: Limacorporate.

Clearance details

Applicant: Limacorporate
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2021-12-06
Decision date: 2022-05-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Villanova Di San Daniele Del Friuli, IT

Download summary PDF View on FDA.gov ↗

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.