Catalog Number

1110-0001-PL

Brand Name

SpineSmith IN:C2 Spinal Fixation System

Version/Model Number

1110-0001-PL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122630

Product Code

OVE

Product Code Name

Intervertebral Fusion Device With Integrated Fixation, Cervical

Public Device Record Key

bad635ff-b6f5-4fbe-954c-4b8a79182137

Public Version Date

April 11, 2022

Public Version Number

7

DI Record Publish Date

February 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-