Duns Number:080474650
Device Description: THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSI THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
Catalog Number
30290143
Brand Name
AUDERE C SPINAL CURETTE STRAIGHT
Version/Model Number
30290143
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
-
Product Code
ODP
Product Code Name
Intervertebral Fusion Device With Bone Graft, Cervical
Public Device Record Key
6681c9c3-17fb-4cd9-96cc-8122a19702fa
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
March 30, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |