Z1 Cemented Hip System— 510(k) K241241
Substantially EquivalentOrchard Medical Development, LLC
FDA 510(k) clearance K241241 for Z1 Cemented Hip System, Substantially Equivalent on 2024-08-27. Applicant: Orchard Medical Development, LLC.
Clearance details
- Applicant
- Orchard Medical Development, LLC
- Product code
- Code LZO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rosemont, IL, US
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.