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AccelFix Spinal Fixation System (Sterile)
EUDAMEDClass IIb (EU MDR)
Ref 8111-65135S
by L&K Biomed
Identity
- Trade Name
- AccelFix Spinal Fixation System (Sterile) EUDAMED
- Device Name
- AccelFix Spinal Fixation System (Sterile) EUDAMED
- Model / Reference
- 8111-65135S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800061329759 EUDAMED
- Basic UDI-DI
- B-08800061329759 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Spinal bone screw, non-bioabsorbable
AccelFix Spinal Fixation System (Sterile) by L&K Biomed — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
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- 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 (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800061329759 | Class IIb | Active |
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Manufacturer
- Manufacturer
- L&K Biomed
- EUDAMED SRN
- KR-MF-000033200
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 79961241-4369-4a60-9c48-cb9d388a9596 61 fields · synced Jun 19, 2026