Duns Number:828660345
Device Description: HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion.
Catalog Number
CP15-10-FG
Brand Name
HyProCure Sizer 10
Version/Model Number
CP15-10-FG
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"
-
For Single-Use
-
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
K042030
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
678ce512-7301-4b94-bd2f-57571cf82f99
Public Version Date
October 26, 2021
Public Version Number
4
DI Record Publish Date
February 14, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |