Odalys - The Odalys is a pedicle screw spinal system. - KISCO INTERNATIONAL

Duns Number:393107719

Device Description: The Odalys is a pedicle screw spinal system.

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More Product Details

Catalog Number

ODPS55730

Brand Name

Odalys

Version/Model Number

Polyaxial screw Ø7 L30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K152098

Product Code Details

Product Code

MNI

Product Code Name

Orthosis, Spinal Pedicle Fixation

Device Record Status

Public Device Record Key

3f3056f5-1193-4719-b933-56fb6f831df8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 02, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KISCO INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 62