TLIF - Transforaminal Lumbar Interbody Fusion System - 11x35 12mm 0 Degrees - NVISION BIOMEDICAL TECHNOLOGIES, INC.

Duns Number:047486041

Device Description: 11x35 12mm 0 Degrees

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

TLIF - Transforaminal Lumbar Interbody Fusion System

Version/Model Number

TL-012-T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K142594

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

84c75d7b-34e3-4032-909c-bd95a7619ee6

Public Version Date

February 24, 2020

Public Version Number

7

DI Record Publish Date

October 19, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NVISION BIOMEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 461
2 A medical device with a moderate to high risk that requires special controls. 1046