Duns Number:117700483
Device Description: LTJ 3.75mm Solid Ti Screw L. 32mm Non Sterile
Catalog Number
-
Brand Name
LTJ
Version/Model Number
81004162333
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
K210268
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
4ec3410c-ee7c-4dd7-99fe-bc491d30618b
Public Version Date
May 10, 2021
Public Version Number
1
DI Record Publish Date
May 01, 2021
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 | 27 |
2 | A medical device with a moderate to high risk that requires special controls. | 42 |