Catalog Number

-

Brand Name

TLIF LITE

Version/Model Number

LFC-002PK3209

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K132907

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Public Device Record Key

c7fd0dc5-1e4e-4c45-aa25-fd8c825cc441

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

October 08, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-