Duns Number:342243334
Device Description: 3.5 TPO SS polyaxial locking plate, broad,left
Catalog Number
150-6235-263
Brand Name
3.5 TPO SS polyaxial locking plate, broad,left
Version/Model Number
150-6235-263
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
-
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
427186a3-2614-4882-9579-c101ffa0b314
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 02, 2016
Package DI Number
EMAH15062352631
Quantity per Package
1
Contains DI Package
EMAH15062352630
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |