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Blue Mountain Cervical Plate System

FDA UDI

Class 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
SCREW FOR CAGE FIXATION FDA UDI
Model / Reference
1 FDA UDI
Description
SCREW FOR CAGE FIXATION FDA UDI

Identifiers

Catalog Number
BM1CPS FDA UDI
Primary DI / UDI-DI
03663422040008 FDA UDI
510(k) Number
K150036 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Blue Mountain Cervical Plate System by Spineway SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K150036 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineway SA

Sources (1)

  • FDA UDI c8a1f610-b870-40b3-b5cb-00402a1db320 37 fields · synced May 31, 2026