← Back to catalogue
Blue Mountain Cervical Plate System
FDA UDIClass II (US FDA UDI)
by Spineway SA
Identity
- Trade Name
- Blue Mountain Cervical Plate System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- CERVICAL CENTRAL SCREW Ø:4,5 L:14mm FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- CERVICAL CENTRAL SCREW Ø:4,5 L:14mm FDA UDI
Identifiers
- Catalog Number
- BM1SC4514 FDA UDI
- Primary DI / UDI-DI
- 03663422040268 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 14 Millimeter FDA UDIOuter Diameter — 4.5 Millimeter FDA UDI
Blue Mountain Cervical Plate System by Spineway SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineway SA
Sources (1)
- FDA UDI a47e09ca-8958-4c1a-9a57-e9ec4c790181 37 fields · synced Jun 1, 2026