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SPS™ Large Fragment
EUDAMEDClass IIb (EU MDR)
Ref 620455SModel 08858251006765UD
by Stryker GmbH
Identity
- Trade Name
- SPS™ Large Fragment EUDAMED
- Device Name
- SPS LARGE FRAGMENT - PLATE - TITANIUM ALLOY - CLASS IIB - STERILE EUDAMED
- Model / Reference
- 08858251006765UD EUDAMED620455S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546540423825 EUDAMED
- Basic UDI-DI
- 08858251006765UD EUDAMED
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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: Orthopaedic fixation plate, non-bioabsorbable
SPS™ Large Fragment by Stryker GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 08858251006765UD | Class IIb | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
- EUDAMED SRN
- CH-MF-000009332
- Authorised Representative
- Stryker European Operations Limited IE-AR-000000092
Sources (1)
- EUDAMED 93ee45bc-2da6-4ff8-b1b4-8a6b909e53d0 61 fields · synced Aug 1, 2026