Duns Number:828660345
Device Description: HyProCure II Positioning Sleeve instrument. For use with the HyProCure II Sinus Tarsi Imp HyProCure II Positioning Sleeve instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
Catalog Number
HYPII-PS
Brand Name
HyProCure II Positioning Sleeve
Version/Model Number
HYPII-PS
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
K142534
Product Code
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
f950c311-9198-4f97-8dfb-e9a0e4b5069a
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 |