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Diverted Bone Tube

FDA UDI

Class II (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Diverted Bone Tube FDA UDI
Generic Name
Polymeric spinal interbody fusion cage FDA UDI
Model / Reference
102-11-100 FDA UDI

Identifiers

Catalog Number
101-1081 FDA UDI
Primary DI / UDI-DI
M7401011081 FDA UDI
510(k) Number
DEN200010 FDA UDI
FDA Product Code
OQB FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3085 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
MRI Safety
MR Unsafe FDA UDI

Diverted Bone Tube by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

DEN200010 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI e943e96e-0f7b-44ee-b4ff-6b48bc3eec59 36 fields · synced May 31, 2026