Catalog Number

SPN-5004

Brand Name

Inion S-1™

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K051821

Product Code

OJB

Product Code Name

Resorbable spinal intervertebral body fixation orthosis - plate

Public Device Record Key

b65c3526-e925-4396-b11f-292c2a1b53fb

Public Version Date

December 24, 2018

Public Version Number

1

DI Record Publish Date

November 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-