Mountaineer Oct Spinal System
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- MOUNTAINEER OCT SPINAL SYSTEM EUDAMEDMOUNTAINEER FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- CONNECTORS FOR CERVICAL FIXATION SYSTEM EUDAMEDMOUNTAINEER OCT SPINAL SYSTEM DUAL WEDDING BAND ASSEMBLY 3.5 x 5.5mm FDA UDI
- Model / Reference
- MOUNTAINEER OCT SYSTEM CONNECTORS EUDAMED188311202 EUDAMEDFDA UDI
- Description
- MOUNTAINEER OCT SPINAL SYSTEM DUAL WEDDING BAND ASSEMBLY 3.5 x 5.5mm FDA UDI
Identifiers
- Catalog Number
- 188311202 FDA UDI
- Primary DI / UDI-DI
- 10705034156729 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a0024462 EUDAMED
- FDA Product Code
- NKG FDA UDIMNI FDA UDIKWP FDA UDI
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3075 FDA UDI888.3070 FDA UDI888.3050 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Cervical spine immobilization system, single-use
A comprehensive overview of the MOUNTAINEER OCT SPINAL SYSTEM medical device, including its features, compliance status, and FAQs.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a0024462 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 (2)
- EUDAMED 2ad86566-fd1c-4876-8704-6ecae8425ba6 61 fields · synced Aug 1, 2026
- FDA UDI 8dcd6d90-7060-4d1e-8e63-e352819075f1 36 fields · synced May 30, 2026