28mm/38D MDM X3 Insert for MDM Liner— 510(k) K233724

Substantially Equivalent

Howmedica Osteonics Corp., Dba Stryker Orthopaedics

FDA 510(k) clearance K233724 for 28mm/38D MDM X3 Insert for MDM Liner, Substantially Equivalent on 2024-03-11. Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

Clearance details

Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Product code
Code LZO
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mahwah, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZO

product code LZO
Death
17
Injury
12,942
Malfunction
1,756
Total
14,715

Source: openFDA MAUDE database, through . 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.