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AccelFix Spinal Fixation System (Sterile)
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 8102-6540S
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) EUDAMEDReduction Mono Axial Screw Ø6.5 , 40mm FDA UDI
- Model / Reference
- 8102-6540S EUDAMEDFDA UDI
- Description
- Reduction Mono Axial Screw Ø6.5 , 40mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800061324167 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800061324167 EUDAMED
- 510(k) Number
- K182544 FDA UDI
- FDA Product Code
- KWQ FDA UDIKWP FDA UDINKB 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
- 888.3060 FDA UDI888.3050 FDA UDI888.3070 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-08800061324167 | 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 6db27ecf-aff5-4331-b96e-beb7f952a222 61 fields · synced Jun 17, 2026
- FDA UDI 61df86ee-d696-457b-adb3-622b0ee52f27 34 fields · synced May 29, 2026