Lumbar Interbody Fusion System (OLLIF) - Lumbar Interbody Fusion System (OLLIF) Graft - ADVANCED RESEARCH MEDICAL LLC

Duns Number:117201206

Device Description: Lumbar Interbody Fusion System (OLLIF) Graft Delivery Tube

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More Product Details

Catalog Number

01-08

Brand Name

Lumbar Interbody Fusion System (OLLIF)

Version/Model Number

01-08

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

-

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

K173947

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

f5a73f74-df6f-4adf-89c1-816b15809e58

Public Version Date

December 07, 2021

Public Version Number

1

DI Record Publish Date

November 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED RESEARCH MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 103