Duns Number:081021000
Device Description: LLIF IMPLANT - 0° x 22MM IMPLANTSLordosis & Heights: 12-15mm x 0° x 60mmCollapsed Width (m LLIF IMPLANT - 0° x 22MM IMPLANTSLordosis & Heights: 12-15mm x 0° x 60mmCollapsed Width (mm): 13.34Expanded Width (mm): 22Collapsed Height (mm): 12.5Expanded Height (mm): 15.5Collapsed Length (mm): 68.76Expanded Length (mm): 61.8
Catalog Number
-
Brand Name
DUALX LLIF 12-15MM x 0 DEG x 60MM
Version/Model Number
12831005020
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K181397
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
65d246d0-0418-4afa-b6e6-52ab13790078
Public Version Date
May 21, 2021
Public Version Number
4
DI Record Publish Date
July 25, 2019
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. | 277 |