Catalog Number

7300-1213

Brand Name

ENDOSKELETON TL

Version/Model Number

7300-1213

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2020

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

-

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

K140055

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Public Device Record Key

6bc48711-aea2-4d61-9004-51e1628b69db

Public Version Date

December 09, 2020

Public Version Number

7

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-