C-Box®

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name: C-Box® FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: SST FDA UDI
Model / Reference: CC-001 FDA UDI
Description: SST FDA UDI

Identifiers

Catalog Number: CC-001 FDA UDI
Primary DI / UDI-DI: M711CC0010 FDA UDI
510(k) Number: K132991 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Spinal implant trial 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial Orthopaedic cement restrictor sizer

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

Similar devices

Also classified as Orthopaedic cement restrictor sizer.

3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II
BIO-PLUG — Biomet Orthopedics, Inc. · Class I
EVOL®ha-C Cervical Interbody System — CUTTING EDGE SPINE · Class II
DISTAL CANAL SIZER — Biomet Orthopedics, Inc. · Class I
3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II
3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II
DISTAL CANAL SIZER — Biomet Orthopedics, Inc. · Class I
3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II

Cleared under the same submission

K132991 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Innovasis, Inc.

Sources (1)

FDA UDI 4f427a18-9e43-4fc1-b676-b463c8548aa0 36 fields · synced May 30, 2026