Catalog Number

ODLS

Brand Name

Odalys

Version/Model Number

Locking cap

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

MNI

Product Code Name

Orthosis, Spinal Pedicle Fixation

Public Device Record Key

68b705a0-2615-4d59-ab9d-ea0d1f47dd07

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 02, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-