Tranquil-L™ - DLIF 40mm-50mm Caddy Base - NEXUS SPINE, L.L.C.

Duns Number:028137605

Device Description: DLIF 40mm-50mm Caddy Base

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More Product Details

Catalog Number

-

Brand Name

Tranquil-L™

Version/Model Number

823225

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

-

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

K170297,K181483,K181702

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

d3eaad0f-835b-46fd-8c4c-fbc33908142b

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEXUS SPINE, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 2529