CAVUX Cervical Cage-T - The CAVUX Cervical Cage-T is a single-use, - PROVIDENCE MEDICAL TECHNOLOGY, INC.

Duns Number:969820245

Device Description: The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.

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More Product Details

Catalog Number

PD-31-100

Brand Name

CAVUX Cervical Cage-T

Version/Model Number

PD-31-100

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

K122801

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

91864f13-7168-4db4-a8b2-5ec314ee9a09

Public Version Date

February 24, 2020

Public Version Number

6

DI Record Publish Date

September 02, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROVIDENCE MEDICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 22