HyProCure Sinus Tarsi Implant
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Basic Information
- Primary DI
- ++M621HYPXXEP
- Basic UDI-DI Code
- B-++M621HYPXXEP
- Reference
- HYP-05, HYP-06, HYP-07, HYP-08, HYP-09, HYP-10
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Graham Medical Technologies, LLC dba GraMedica
Additional Description
The HyProCure system consists of various size implants and an instrumentation set. The HyProCure Implant 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 or abnormal, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion. The implant is placed into the sinus tarsi without the need for drilling. The implants are provided sterile for single use only and available in 6 sizes ranging from 05mm to 10mm (size of the threaded portion). Each implant is packaged separately and indicated for single use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P090605 | FOOT ENDORTHESIS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | US19/819943475 | SGS Belgium NV | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).