ENDOSKELETON TA VBR - 7 DEG LORDOTIC, TRIAL, STANDARD, 20MM - TITAN SPINE, LLC

Duns Number:623316978

Device Description: 7 DEG LORDOTIC, TRIAL, STANDARD, 20MM

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More Product Details

Catalog Number

2156-9120

Brand Name

ENDOSKELETON TA VBR

Version/Model Number

2156-9120

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 21, 2020

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

K032812

Product Code Details

Product Code

MQP

Product Code Name

SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Record Status

Public Device Record Key

cdf226b7-f9e2-403e-b744-ebb80983c2db

Public Version Date

December 09, 2020

Public Version Number

7

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TITAN SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 243
2 A medical device with a moderate to high risk that requires special controls. 5255