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Uss Ii
EUDAMEDClass IIb (EU MDR)
Ref 04.607.253Model USS - Universal Spine System Bone Screw
by Synthes GmbH
Identity
- Trade Name
- USS II EUDAMED
- Device Name
- USS Bone Screw Pedicle Screw Vertebral Body Screw Cancellous Low Profile Polyaxial Perforated Side-Opening EUDAMED
- Model / Reference
- USS - Universal Spine System Bone Screw EUDAMED04.607.253 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819186071 EUDAMED
- Basic UDI-DI
- 7611819a00269JW EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Spinal bone screw, non-bioabsorbable
Uss Ii by Synthes GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7611819a00269JW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (1)
- EUDAMED a075bcc8-fbd4-43c2-9fee-e38a5b1b555d 61 fields · synced Jun 18, 2026