ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
FDA Regulatory Profile
ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2941-2024, Class II) was initiated on July 4, 2024. Its most recent 510(k) clearance was granted on February 21, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2941-2024 | Class II | FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System | July 4, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241983 | Fassier-Duval Telescoping IM System | February 21, 2025 |