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Uss
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 498.283Model Posterior Rods for Spine Titanium Rod Ø 6.0mm
by Synthes GmbH
Identity
- Trade Name
- USS EUDAMED
- Device Name
- Titanium Rod Ø 6.0mm EUDAMED
- Model / Reference
- Posterior Rods for Spine Titanium Rod Ø 6.0mm EUDAMED498.283 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819782075 EUDAMED
- Basic UDI-DI
- 7611819a00406JG EUDAMED
- EMDN Code
- P09070304 SPINE FIXATION SYSTEM CONNECTORS 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: Bone-screw internal spinal fixation system connector
Uss by Synthes GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
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- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111358 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 7611819a00406JG | 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 (2)
- EUDAMED c5cd2587-557e-4ea1-b973-171039ec7268 61 fields · synced Jun 19, 2026
- FDA 510(k) K111358 1 fields · synced May 18, 2026