FDA.reportPublic FDA data

HyProCure II Sinus Tarsi Stent Size 09

Primary DI
M621HYPII090
Brand
HyProCure II Sinus Tarsi Stent Size 09
Company
Graham Medical Technologies, L.L.C.
Model
HYP II-09
Catalog number
HYP II-09
Device description
HyProCure II Sinus Tarsi Implant Size 09. Indications: HyProCure II (HYP II and HYP IIs) 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.
Published
2017-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142534000HyProCure IIGraham Medical Technologies, LLC Dba Gramedica2014-10-03HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M621HYPII090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Subtalar implant, non-bioabsorbable, sterileA sterile device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
586-677-9600xx@xx.xx

Regulatory Flags#

DUNS number
828660345
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M621CARRYINGCASE0osteo-WEDGE Opening Wedge Bone Locking System OWCarryingCase-KitCarryingCase2017-02-14
M621CP1505FG0HyProCure Sizer 05CP15-05-FGCP15-05-FG2017-02-14
M621CP1506FG0HyProCure Sizer 06CP15-06-FGCP15-06-FG2017-02-14
M621CP1507FG0HyProCure Sizer 07CP15-07-FGCP15-07-FG2017-02-14
M621CP1508FG0HyProCure Sizer 08CP15-08-FGCP15-08-FG2017-02-14
M621CP1509FG0HyProCure Sizer 09CP15-09-FGCP15-09-FG2017-02-14
M621CP1510FG0HyProCure Sizer 10CP15-10-FGCP15-10-FG2017-02-14
M621GM150010osteo-WEDGE Depth Gauge SleeveGM-150-01GM-150-012017-04-04
M621GM150020osteo-WEDGE Depth Gauge GM-150-02GM-150-022017-04-04
M621GM150030osteo-WEDGE DriverGM-150-03GM-150-032017-04-04
M621GM150040osteo-WEDGE Screw Retainer SleeveGM-150-04GM-150-042017-04-04
M621GM160010osteo-WEDGE Drill GuideGM-160-01GM-160-012017-04-04
M621GM501000osteo-WEDGE Bone Plate 00mmGM-501-00GM-501-002017-04-04
M621GM501020osteo-WEDGE Bone Plate 02mmGM-501-02GM-501-022017-04-04
M621GM501040osteo-WEDGE Bone Plate 04mmGM-501-04GM-501-042017-04-04
M621GM501060osteo-WEDGE Bone Plate 06mmGM-501-06GM-501-062017-04-04
M621GM501080osteo-WEDGE Bone Plate 08mmGM-501-08GM-501-082017-04-04
M621GM501100osteo-WEDGE Bone Plate 10mmGM-501-10GM-501-102017-04-04
M621GMDSLL0Graham Decompression Scissors, Curved Left "11-470-11-CL (14cm/5.5"")"GM-DS-LL2017-01-27
M621GMDSLR0Graham Decompression Scissors, Curved Right"11-470-11-CR (14cm/5.5"")"GM-DS-LR2017-01-27

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