Catalog Number

1058-414-211

Brand Name

Kyocera Medical Technologies, Inc.

Version/Model Number

S 158

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

K153250,K182007

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Public Device Record Key

29e2aeff-a7eb-4cb0-a4d5-1db69a0c3ff5

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

January 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-