Endoskeleton TL - Interbody Fusion Device nanoLOCK Surface - TITAN SPINE, LLC

Duns Number:623316978

Device Description: Interbody Fusion Device nanoLOCK Surface Technology Parallel 45 (M/L) 26 (A/P) 11 mm

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More Product Details

Catalog Number

7100-2211-N

Brand Name

Endoskeleton TL

Version/Model Number

7100-2211-N

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

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

K140055,K141953

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

7782e81d-ed2e-45ce-a9bb-93592efc5077

Public Version Date

December 09, 2020

Public Version Number

7

DI Record Publish Date

September 17, 2015

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