Duns Number:623316978
Device Description: Hyperlordotic Instrument Tray Sys, 16, 20°
Catalog Number
2900-1052
Brand Name
ENDOSKELETON® TAS
Version/Model Number
2900-1052
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 18, 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
K111626
Product Code
OVD
Product Code Name
Intervertebral fusion device with integrated fixation, lumbar
Public Device Record Key
8f8f40e1-0618-4c2f-bc44-e6617cdeffc2
Public Version Date
September 16, 2022
Public Version Number
12
DI Record Publish Date
April 26, 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 |
---|---|---|
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 |