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Apex Femoral Nailing System Kit
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref INS-1133
by OrthoXel DAC
Identity
- Trade Name
- Apex Femoral Nailing System Kit EUDAMEDApex FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Apex Femoral Nailing System Kit EUDAMEDFDA UDI
- Model / Reference
- INS-1133 EUDAMEDFDA UDI
- Description
- Apex Femoral Nailing System Kit FDA UDI
Identifiers
- Catalog Number
- INS-1133 FDA UDI
- Primary DI / UDI-DI
- 05391529581626 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529581626 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Apex Femoral Nailing System Kit by OrthoXel DAC — Class I — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Manufacturer's product page: Apex Femoral Antegrade Nailing System
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181375 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529581626 | Class I | Active |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (3)
- EUDAMED 6b12c64d-f474-41b0-824c-b926ed810ff2 61 fields · synced Jul 19, 2026
- FDA UDI 6039db97-13fb-4161-8661-725fb57065b4 36 fields · synced May 30, 2026
- FDA 510(k) K181375 1 fields · synced May 18, 2026