Catalog Number

-

Brand Name

TLIF Curved-L, 36 x 16mm

Version/Model Number

PL3616

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 2017

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

K092017

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

0ae09dc5-752c-4698-84bf-7c8ec3603309

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

August 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-