HyProCure II Positioning Sleeve - HyProCure II Positioning Sleeve instrument. For - Gramedica

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GRAMEDICA" Characteristics
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