OneLIF™ - Retention Plate, Anterior-Only, Large, 10 mm - Novapproach Spine LLC

Duns Number:059260001

Device Description: Retention Plate, Anterior-Only, Large, 10 mm

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More Product Details

Catalog Number

013-320-1000

Brand Name

OneLIF™

Version/Model Number

013-320-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K211769

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

52531988-b73b-4c0e-8a7c-ebe15df4d21d

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVAPPROACH SPINE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 156