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 rod FDA UDI
- Device Name
- RODS FOR CERVICAL FIXATION SYSTEM EUDAMEDMOUNTAINEER OCT SPINAL SYSTEM PRE-BENT SPINAL ROD 3.5 x 120mm - 85mm FDA UDI
- Model / Reference
- MOUNTAINEER OCT SYSTEM OC RODS EUDAMED188363200 EUDAMEDFDA UDI
- Description
- MOUNTAINEER OCT SPINAL SYSTEM PRE-BENT SPINAL ROD 3.5 x 120mm - 85mm FDA UDI
Identifiers
- Catalog Number
- 188363200 FDA UDI
- Primary DI / UDI-DI
- 10705034159027 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a002435Y EUDAMED
- FDA Product Code
- KWP FDA UDIMNI FDA UDINKG FDA UDI
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 FDA UDI888.3075 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
Mountaineer Oct Spinal System by Medos International Sarl — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cervical spine immobilization system, single-use.
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- PMT® Halo Systems — Pmt Corp. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a002435Y | 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 dfe8d245-cb1c-4f60-8c8f-92468946e331 61 fields · synced Jun 18, 2026
- FDA UDI 161e25f8-9bf3-4d67-b06d-ff7f3c593e7d 36 fields · synced May 29, 2026