AccelFix Spinal Fixation System (Sterile)
EUDAMEDFDA UDIClass IIb (EU MDR)
by L&K Biomed
Identity
- Trade Name
- AccelFix Spinal Fixation System (Sterile) EUDAMEDAccelFix Spinal Fixation System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- AccelFix Spinal Fixation System (Sterile) EUDAMEDAxial Connector Ø5.7, Ø5.7, 35x11mm FDA UDI
- Model / Reference
- 1002-5757S EUDAMEDFDA UDI
- Description
- Axial Connector Ø5.7, Ø5.7, 35x11mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800061391848 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800061391848 EUDAMED
- 510(k) Number
- K182544 FDA UDI
- FDA Product Code
- NKB FDA UDIKWP FDA UDIKWQ FDA UDI
- EMDN Code
- P09070304 SPINE FIXATION SYSTEM CONNECTORS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI888.3060 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Yes
Manufacturing Date
Yes
Category: Bone-screw internal spinal fixation system connector
AccelFix Spinal Fixation System (Sterile) by L&K Biomed — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800061391848 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- L&K Biomed
- EUDAMED SRN
- KR-MF-000033200
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED b47de1b7-9740-48f3-922b-9fb5006176e3 61 fields · synced Jun 19, 2026
- FDA UDI 4e753c56-fce9-42e5-a3ba-1c23153b31d1 34 fields · synced May 29, 2026