FDA.reportPublic FDA data

HyProCure Instrument Set

Primary DI
M621HYPINSTRAY0
Brand
HyProCure Instrument Set
Company
Graham Medical Technologies, L.L.C.
Model
HYP-INS-TRAY
Catalog number
HYP-INS-TRAY
Device description
HyProCure (reusable) Instrument Set. The instrument set contains six Trial Sizers (05mm thru 10mm), one Driver and three Guide Wires. 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.
Published
2017-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K042030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042030000HYPROCURE SUBTALAR IMPLANT SYSTEMGraham Medical Technologies, LLC2004-09-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M621HYPINSTRAY0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
828660345
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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