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C-Box®

FDA UDI

Class I (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name
C-Box® FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
12.5 x 8 x 13.5mm Cervical Cage Sizer, SST FDA UDI
Model / Reference
CC-008 FDA UDI
Description
12.5 x 8 x 13.5mm Cervical Cage Sizer, SST FDA UDI

Identifiers

Primary DI / UDI-DI
M711CC0080 FDA UDI
510(k) Number
K132991 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Width — 13.5 Millimeter FDA UDI
Height — 8 Millimeter FDA UDI
Length — 12.5 Millimeter FDA UDI

Category: Spinal implant trial

C-Box® by Innovasis, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K132991 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innovasis, Inc.

Sources (1)

  • FDA UDI c55b22a1-64dd-4562-8fb7-49a5534cb05d 36 fields · synced May 31, 2026