Duns Number:946657160
Device Description: Consensus CT THA hip guide
Catalog Number
HPC-CO01-01-01
Brand Name
Bespoke
Version/Model Number
HPC-CO01-01-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 21, 2017
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"
-
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
K150780
Product Code
PLW
Product Code Name
Acetabular Cup Orientation System
Public Device Record Key
ef9fb84f-6944-4bdb-8960-fd33984a5b60
Public Version Date
November 27, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |