VERTACONNECT 11° - The VERTACONNECT TLIF Spreadable Lumbar Cage is a - SIGNUS Medizintechnik GmbH

Duns Number:344203948

Device Description: The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared int The VERTACONNECT TLIF Spreadable Lumbar Cage is a spacer for implantation in aprepared intervertebral disc space of the lumbar spine. Its design offers stable contactsurfaces, toothed implant/bone surfaces and large cage windows. The open implant design supports a bony construction of the intervertebral disc space. The implants consist of a cage and a pre-assembled expansion element.

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More Product Details

Catalog Number

CAT341610

Brand Name

VERTACONNECT 11°

Version/Model Number

Lumbar cage, angled

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

K203327

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

c319095b-170b-4f23-a687-9ca30b38653e

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIGNUS MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 522
2 A medical device with a moderate to high risk that requires special controls. 1837