HyProCure Size 10 HYP-10

GUDID M621HYP100

HyProCure Sinus Tarsi Implant Size 10. 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

Subtalar implant, non-bioabsorbable, sterile

• Primary Device ID: M621HYP100
• NIH Device Record Key: 3d53fe4b-68fc-484d-add4-34a546072689
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyProCure Size 10
• Version Model Number: HYP-10
• Catalog Number: HYP-10
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M621HYP100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042030

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-26
• Device Publish Date: 2017-04-04

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: 2021-10-26 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.