Identity
- Trade Name
- KHEIRON EUDAMEDFDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Vis pédiculaire Ø7.5 L45mm EUDAMEDØ7.5 L45mm pedicle screw FDA UDI
- Model / Reference
- 24PW75045 EUDAMEDFDA UDI
- Description
- Ø7.5 L45mm pedicle screw FDA UDI
Identifiers
- Catalog Number
- 24PW75045 FDA UDI
- Primary DI / UDI-DI
- 03701313001056 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701313001056 EUDAMED
- 510(k) Number
- K201659 FDA UDI
- FDA Product Code
- NKB FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDIOuter Diameter — 7.5 Millimeter FDA UDI
The KHEIRON device is a medical device designed for the administration of sterile medications to patients with certain health conditions. It features Class IIb FDA clearance and meets all relevant regulatory requirements. The device has been engineered to meet specific anatomical needs, making it an ideal choice for targeted treatments.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03701313001056 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.m.a.i.o
- EUDAMED SRN
- FR-MF-000002399
Sources (2)
- EUDAMED 7e01d5eb-2d8c-4628-b3eb-445023dcca25 61 fields · synced Jun 25, 2026
- FDA UDI e44ed468-e0fe-419a-baa4-f11ef3d43366 37 fields · synced May 30, 2026