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Monoaxial Pedicle Screw
EUDAMEDClass IIb (EU MDR)
Ref F15AB-PA00242Ref F15AB-PA00233Ref F15AB-PA00240Ref F15AB-PA00231Ref F15AB-PA00234Ref F15AB-PA00230Ref F15AB-PA00249Ref F15AB-PA00243Ref F15AB-PA00237Ref F15AB-PA00225Ref F15AB-PA00239Ref F15AB-PA00232Ref F15AB-PA00226Ref F15AB-PA00227
Identity
- Trade Name
- Monoaxial Pedicle Screw EUDAMED
- Device Name
- Non-sterile Spinal Internal Fixation Systems EUDAMED
- Model / Reference
- F15AB-PA00242 EUDAMEDF15AB-PA00233 EUDAMEDF15AB-PA00240 EUDAMEDF15AB-PA00231 EUDAMEDF15AB-PA00234 EUDAMEDF15AB-PA00230 EUDAMEDF15AB-PA00249 EUDAMEDF15AB-PA00243 EUDAMEDF15AB-PA00237 EUDAMEDF15AB-PA00225 EUDAMEDF15AB-PA00239 EUDAMEDF15AB-PA00232 EUDAMEDF15AB-PA00226 EUDAMEDF15AB-PA00227 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942512074831 EUDAMED06942512074664 EUDAMED06942512074817 EUDAMED06942512074640 EUDAMED06942512074671 EUDAMED06942512074633 EUDAMED06942512074947 EUDAMED06942512074848 EUDAMED06942512074749 EUDAMED06942512074565 EUDAMED06942512074763 EUDAMED06942512074657 EUDAMED06942512074572 EUDAMED06942512074589 EUDAMED
- Basic UDI-DI
- B-06942512074831 EUDAMEDB-06942512074664 EUDAMEDB-06942512074817 EUDAMEDB-06942512074640 EUDAMEDB-06942512074671 EUDAMEDB-06942512074633 EUDAMEDB-06942512074947 EUDAMEDB-06942512074848 EUDAMEDB-06942512074749 EUDAMEDB-06942512074565 EUDAMEDB-06942512074763 EUDAMEDB-06942512074657 EUDAMEDB-06942512074572 EUDAMEDB-06942512074589 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Monoaxial Pedicle Screw by Wuhan Mindray Scientific Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, 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-06942512074831 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuhan Mindray Scientific Co., Ltd.
- EUDAMED SRN
- CN-MF-000032692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (14)
- EUDAMED e1323bb4-f750-4131-b8fe-dc81ae24b52f 61 fields · synced Oct 6, 2026
- EUDAMED a96548e1-e9f2-448a-a2b0-e0a7a4ba7375 61 fields · synced May 16, 2026
- EUDAMED bc8055d9-410c-4f87-84ab-b4570ba9a416 61 fields · synced May 17, 2026
- EUDAMED f28ba17f-bb90-4ada-80f0-e87cbf2c428e 61 fields · synced May 17, 2026
- EUDAMED f82bde3f-1e2b-4e8e-ab35-b228bf500e89 61 fields · synced May 17, 2026
- EUDAMED c620173d-5a85-4ff9-8b2c-30488fbd311f 61 fields · synced May 17, 2026
- EUDAMED d875f53e-1f1c-48e4-8e1a-4b0c65b54874 61 fields · synced May 17, 2026
- EUDAMED c22082fc-ddaa-4c36-9050-a9da599c860a 61 fields · synced May 17, 2026
- EUDAMED 0a253078-bd60-424c-9722-808d4afcaffd 61 fields · synced May 18, 2026
- EUDAMED 52e55343-7945-4e89-9b6c-176a8e2df2ac 61 fields · synced May 18, 2026
- EUDAMED 964afcec-9714-43e2-9274-6f548e32de98 61 fields · synced May 18, 2026
- EUDAMED 4a31d218-fb36-4a6e-844c-074811c2cba7 61 fields · synced May 18, 2026
- EUDAMED ce3aadf7-74c7-4f09-b4aa-5ce28533daae 61 fields · synced May 18, 2026
- EUDAMED 7b371b18-5df2-430c-86a5-25126cff0af7 61 fields · synced May 19, 2026