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Confidence Spinal Cement System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 283903611Model CONFIDENCE Spinal Cement System Needles InstrumentsRef 283906201Model Confidence Instruments for Cement, Fitting and ApplicationRef 283906200Ref 283903413Ref 283910000Model CONFIDENCE Spinal Cement System - 11cc Kit
Identity
- Trade Name
- CONFIDENCE SPINAL CEMENT SYSTEM EUDAMEDFDA UDI
- Generic Name
- Bone access cannula FDA UDIOrthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- Confidence Biopsy Needle / Introducer Needle EUDAMEDConfidence Cement Pump Reservoir Mixer Holder Adaptor EUDAMEDCONFIDENCE Spinal Cement System - 11cc Kit EUDAMEDCONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 13G x 4 Inches FDA UDICONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11cc FDA UDICONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G x 6 Inches FDA UDI
- Model / Reference
- CONFIDENCE Spinal Cement System Needles Instruments EUDAMED283903611 EUDAMEDFDA UDIConfidence Instruments for Cement, Fitting and Application EUDAMED283906201 EUDAMED283903413 EUDAMEDFDA UDI283910000 EUDAMEDFDA UDI283906200 EUDAMEDCONFIDENCE Spinal Cement System - 11cc Kit EUDAMED
- Description
- CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 13G x 4 Inches FDA UDICONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11cc FDA UDICONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G x 6 Inches FDA UDI
Identifiers
- Catalog Number
- 283903413 FDA UDI283910000 FDA UDI283903611 FDA UDI
- Primary DI / UDI-DI
- 10705034209494 EUDAMEDFDA UDI10705034209586 EUDAMED10705034209463 EUDAMEDFDA UDI10705034209623 EUDAMEDFDA UDI10705034209579 EUDAMED
- Basic UDI-DI
- 0705034a0009365 EUDAMED0705034a000896E EUDAMED0705034a000966B EUDAMED
- 510(k) Number
- K060300 FDA UDI
- FDA Product Code
- GAA FDA UDINDN FDA UDI
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMEDP099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Bone access cannula FDA UDIOrthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDIClass III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4800 FDA UDI888.3027 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Medical Purpose
- The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE High Viscosity Spinal Cement, which is indicated for the augmentation of pathological fractures of the vertebral body in skeletally mature patients using vertebroplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma). CONFIDENCE High Viscosity Spinal cement is for single-use and is not reusable. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraosseous infusion kit
Confidence Spinal Cement System by Medos International Sarl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a0009365 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (8)
- EUDAMED 6ddf37ed-b576-44a2-8a21-0912947d6a32 61 fields · synced Aug 2, 2026
- EUDAMED 8ea555bd-00d4-480f-a090-38a3f9f037bc 61 fields · synced May 16, 2026
- FDA UDI f7b3cb69-a417-421c-ad4f-783311a478ff 35 fields · synced May 29, 2026
- FDA UDI 36ae6f48-2730-49ab-a4c4-8ec751f71b0f 37 fields · synced May 30, 2026
- FDA UDI 4330b2a6-e6d3-46fe-b451-a0e5ba372829 35 fields · synced May 30, 2026
- EUDAMED 7f9b87fd-fe67-485a-8d33-14598e49ccad 61 fields · synced Jul 9, 2026
- EUDAMED 005602da-7982-4969-9a23-179e7f1eefd0 61 fields · synced Jul 22, 2026
- EUDAMED dcf703f4-9ba9-40c8-b32a-6d728f6e5505 61 fields · synced Aug 2, 2026