Duns Number:003489810
Device Description: Straight Implant Soft Case 26mm x 6Deg
Catalog Number
-
Brand Name
TrellOss™
Version/Model Number
200M5110
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171140
Product Code
MAX
Product Code Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Public Device Record Key
15e4b77b-d0b6-466c-a8d9-614c5d005470
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
July 24, 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 | 1102 |
2 | A medical device with a moderate to high risk that requires special controls. | 4259 |
U | Unclassified | 91 |