HyProCure Sizer 10 CP15-10-FG

GUDID M621CP1510FG0

HyProCure Sizer 10. Reusable instrument, 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.

Gramedica

Orthopaedic prosthesis implantation instrument, reusable

Primary Device ID	M621CP1510FG0
NIH Device Record Key	678ce512-7301-4b94-bd2f-57571cf82f99
Commercial Distribution Status	In Commercial Distribution
Brand Name	HyProCure Sizer 10
Version Model Number	CP15-10-FG
Catalog Number	CP15-10-FG
Company DUNS	828660345
Company Name	Gramedica
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx
Phone	586-677-9600
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M621CP1510FG0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042030

FDA Product Code

HWC	Screw, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

[M621CP1510FG0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2021-10-26
Device Publish Date	2017-02-14

Devices Manufactured by Gramedica

M621CARRYINGCASE0 - osteo-WEDGE Opening Wedge Bone Locking System	2021-10-26 osteo-WEDGE Opening Wedge Bone Locking System -Kit (containing non-sterile single use implants (2.5mm locking bone screws, 3.0mm
M621CP1505FG0 - HyProCure Sizer 05	2021-10-26 HyProCure Sizer 05. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
M621CP1506FG0 - HyProCure Sizer 06	2021-10-26 HyProCure Sizer 06. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is
M621CP1507FG0 - HyProCure Sizer 07	2021-10-26 HyProCure Sizer 07. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
M621CP1508FG0 - HyProCure Sizer 08	2021-10-26 HyProCure Sizer 08. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
M621CP1509FG0 - HyProCure Sizer 09	2021-10-26 HyProCure Sizer 09. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is a
M621CP1510FG0 - HyProCure Sizer 10	2021-10-26HyProCure Sizer 10. Reusable instrument, 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.
M621CP1510FG0 - HyProCure Sizer 10	2021-10-26 HyProCure Sizer 10. Reusable instrument, for use with the HyProCure Sinus Tarsi Implant System. Indications: HyProCure is
M621GM150010 - osteo-WEDGE Depth Gauge Sleeve	2021-10-26 osteo-WEDGE Depth Gauge Sleeve, a reusable instrument, for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System.

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