Conformity Stem Extension Line, #0— 510(k) K243466
Substantially EquivalentUnited Orthopedic Corporation
FDA 510(k) clearance K243466 for Conformity Stem Extension Line, #0, Substantially Equivalent on 2025-01-06. Applicant: United Orthopedic Corporation.
Clearance details
- Applicant
- United Orthopedic Corporation
- Product code
- Code LZO
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsinchu City, TW
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.