← Back to catalogue

TirboLOX-C Cervical IBFD

FDA UDI

Class II (US FDA UDI)

by Captiva Spine

Identity

Trade Name
TirboLOX-C Cervical IBFD FDA UDI
Generic Name
Spinal fusion sphere FDA UDI
Device Name
Parallel 0° Cage 17mm x 14mm x 7mm FDA UDI
Model / Reference
18100-0717 FDA UDI
Description
Parallel 0° Cage 17mm x 14mm x 7mm FDA UDI

Identifiers

Primary DI / UDI-DI
M7391810007170 FDA UDI
510(k) Number
K181229 FDA UDI
FDA Product Code
ODP 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-C Cervical 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

K181229 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Captiva Spine

Sources (1)

  • FDA UDI 9d92aff6-ff2d-49a7-b52d-f3812109a72a 35 fields · synced May 29, 2026