Orthopediatrics® Pedinail™ Intramedullary Nailing System
by OrthoPediatrics Corp. 130 variants
Ref 10-1500-027-SModel 00-1500-6530
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0841132115002S 00841132195918 | Date21 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- 00-1500-6530, 10-1500-027-S
- Primary DI / UDI-DI
- 00841132195918
- Basic UDI-DI
- 0841132115002S
- EMDN Code
- P09120604 Osteosynthesis nail-screw systems
- Device Class
- Class IIb
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000001776
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Orthopediatrics Corp.
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No