SeaSpine Spacer System - Ventura NanoMetalene - Ventura NM Sterile Implant, 11mm x 28mm x 8mm - SEASPINE ORTHOPEDICS CORPORATION

Duns Number:079840876

Device Description: Ventura NM Sterile Implant, 11mm x 28mm x 8mm

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


More Product Details

Catalog Number

33-6908-S

Brand Name

SeaSpine Spacer System - Ventura NanoMetalene

Version/Model Number

33-6908-S

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

K162715

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

4842ec41-b1bb-4f9d-8b4c-15689e245160

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

November 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SEASPINE ORTHOPEDICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5602
2 A medical device with a moderate to high risk that requires special controls. 14020
U Unclassified 21