Inion S-1™ - Plate, 29 x 19 x 2.0 mm - Inion Oy

Duns Number:367994657

Device Description: Plate, 29 x 19 x 2.0 mm

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More Product Details

Catalog Number

SPN-5014

Brand Name

Inion S-1™

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K071810

Product Code Details

Product Code

OJB

Product Code Name

Resorbable spinal intervertebral body fixation orthosis - plate

Device Record Status

Public Device Record Key

2efc14a9-de87-43d0-ae19-25724e19b86e

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INION OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 201
2 A medical device with a moderate to high risk that requires special controls. 473