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TirboLOX-L Lumbar IBFD

FDA UDI

Class II (US FDA UDI)

by Captiva Spine

Identity

Trade Name
TirboLOX-L Lumbar IBFD FDA UDI
Generic Name
Spinal fusion sphere FDA UDI
Device Name
3D Straight Cage TH 25 x 12mm FDA UDI
Model / Reference
19128-2512 FDA UDI
Description
3D Straight Cage TH 25 x 12mm FDA UDI

Identifiers

Primary DI / UDI-DI
M7391912825120 FDA UDI
510(k) Number
K180990 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Spinal fusion sphere FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Spinal fusion sphere

TirboLOX-L Lumbar IBFD by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fusion sphere.

Cleared under the same submission

K180990 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Captiva Spine

Sources (1)

  • FDA UDI 174d38e7-0378-4cec-b4e4-a810e8142620 35 fields · synced May 30, 2026