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AccelFix Spinal Fixation System (Sterile)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1385-1060S
by L&K Biomed
Identity
- Trade Name
- AccelFix Spinal Fixation System (Sterile) EUDAMEDAccelFix Spinal Fixation System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- AccelFix Spinal Fixation System (Sterile) EUDAMEDPoly Axial Screw (Full Thread), 10.0x60mm FDA UDI
- Model / Reference
- 1385-1060S EUDAMEDFDA UDI
- Description
- Poly Axial Screw (Full Thread), 10.0x60mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809986475664 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809986475664 EUDAMED
- 510(k) Number
- K200794 FDA UDI
- FDA Product Code
- NKB FDA UDIKWQ FDA UDIKWP 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 UDI888.3060 FDA UDI888.3050 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Spinal bone screw, non-bioabsorbable
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 Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- EVEREST® Spinal System — K2M, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809986475664 | 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 5026f7a8-e81c-4255-97c2-e1f4f04c0d7b 61 fields · synced Jun 18, 2026
- FDA UDI a8a1084a-d3c6-4d47-8a2c-22f423202d3c 34 fields · synced May 29, 2026