Identity
- Trade Name
- MOUNTAINEER FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- MOUNTAINEER OCT SPINAL SYSTEM HEAD-TO-HEAD CONNECTOR 42mm FDA UDI
- Model / Reference
- 188341042 FDA UDI
- Description
- MOUNTAINEER OCT SPINAL SYSTEM HEAD-TO-HEAD CONNECTOR 42mm FDA UDI
Identifiers
- Catalog Number
- 188341042 FDA UDI
- Primary DI / UDI-DI
- 10705034158631 FDA UDI
- FDA Product Code
- KWP FDA UDIMNI FDA UDINKG FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 FDA UDI888.3075 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mountaineer by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K042508 also covers:
K151885 also covers:
K190895 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (1)
- FDA UDI 515035f0-6a05-4cb5-8596-4c7860a9145f 37 fields · synced May 31, 2026