Duns Number:969820245
Device Description: The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available The DTRAX Cervical Cage-B 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.
Catalog Number
-
Brand Name
DTRAX Cervical Cage-B
Version/Model Number
PD-31-200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 2019
Issuing Agency
In GS1
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
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
77b230fd-78dd-437d-bef1-88fd04d44544
Public Version Date
April 10, 2019
Public Version Number
5
DI Record Publish Date
September 15, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |