Duns Number:080474650
Device Description: The AUDERE Posterior Lumbar Spacer System consists of implants, trials and instruments. T The AUDERE Posterior Lumbar Spacer System consists of implants, trials and instruments. The AUDERE Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.
Catalog Number
10201100
Brand Name
AUDERE POSTERIOR LUMBAR SPACER SYSTEM
Version/Model Number
10201100
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
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
K160699
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
4cbb80f0-2cdf-4085-b58d-f7e329b5c389
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
May 29, 2017
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 |