Duns Number:623316978
Device Description: Interbody Fusion Device 4 Degree Standard 7mm
Catalog Number
4114-2507
Brand Name
ENDOSKELETON® TT
Version/Model Number
4114-2507
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2020
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
K083714
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
074b56a8-c714-4eea-83ce-dc097651ad81
Public Version Date
December 09, 2020
Public Version Number
4
DI Record Publish Date
June 10, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 243 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5255 |