Duns Number:183641617
Device Description: Longbow Ti, 9mm x 50mm x 7 Degree
Catalog Number
85-1550-709T
Brand Name
Longbow Ti
Version/Model Number
85-1550-709T
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
K190721
Product Code
MAX
Product Code Name
Intervertebral fusion device with bone graft, lumbar
Public Device Record Key
a8850678-5c15-407f-a5d8-432b2059d5e6
Public Version Date
November 27, 2019
Public Version Number
1
DI Record Publish Date
November 19, 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 | 315 |
2 | A medical device with a moderate to high risk that requires special controls. | 9180 |
U | Unclassified | 47 |