Mountaineer Oct Spinal System
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- MOUNTAINEER OCT SPINAL SYSTEM EUDAMEDMOUNTAINEER FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Mountaineer Clamp Tap Drill Bender Feeler Torque Template EUDAMEDMOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL FLEX SHAFT DRILL 3.5mm FDA UDI
- Model / Reference
- MOUNTAINEER OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED288311035 EUDAMEDFDA UDI
- Description
- MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL FLEX SHAFT DRILL 3.5mm FDA UDI
Identifiers
- Catalog Number
- 288311035 FDA UDI
- Primary DI / UDI-DI
- 10705034221748 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a001465Z EUDAMED
- Direct Marketing DI
- 10705034221748 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical implant template, reusable
Mountaineer Oct Spinal System by Medos International Sarl — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132332 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0705034a001465Z | Class I | Active |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (3)
- EUDAMED e34e0f8b-3df9-44b9-9615-004ad816f4f7 61 fields · synced Jun 19, 2026
- FDA UDI e7d70678-3bad-43bc-a56c-e452787d18e0 35 fields · synced May 30, 2026
- FDA 510(k) K132332 1 fields · synced May 18, 2026