Gramedica

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Screw, Fixation, Bone (HWC) (10)

Premarket Exempt

No Yes

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HyProCure Size 09 - M621HYP090 Catalog Number : HYP-09

Device Description : HyProCure Sinus Tarsi Implant Size 09. Indications: HyProCure is a talotars HyProCure Sinus Tarsi Implant Size 09. 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure Size 10 - M621HYP100 Catalog Number : HYP-10

Device Description : HyProCure Sinus Tarsi Implant Size 10. Indications: HyProCure is a talotarsa 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Guide Wire - M621HYPGUIDEWIRES0 Catalog Number : HYP-GuideWires

Device Description : Guide Wire, a reusable instrument, for use with the HyProCure or HyProCure II Si Guide Wire, a reusable instrument, for use with the HyProCure or HyProCure II Sinus Tarsi Implant System. Indications: HyProCure 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure II Sinus Tarsi Stent Size 06 - M621HYPII060 Catalog Number : HYP II-06

Device Description : HyProCure II Sinus Tarsi Implant Size 06. Indications: HyProCure II (HYP II an HyProCure II Sinus Tarsi Implant Size 06. 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure II Sinus Tarsi Stent Size 07 - M621HYPII070 Catalog Number : HYP II-07

Device Description : HyProCure II Sinus Tarsi Implant Size 07. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 07. 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure II Sinus Tarsi Stent Size 08 - M621HYPII080 Catalog Number : HYP II-08

Device Description : HyProCure II Sinus Tarsi Implant Size 08. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 08. 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure II Sinus Tarsi Stent Size 09 - M621HYPII090 Catalog Number : HYP II-09

Device Description : HyProCure II Sinus Tarsi Implant Size 09. Indications: HyProCure II (HYP II a 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure II Sinus Tarsi Stent Size 10 - M621HYPII100 Catalog Number : HYP II-10

Device Description : HyProCure II Sinus Tarsi Implant Size 10. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 10. 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure II Sinus Tarsi Stent Size 11 - M621HYPII110 Catalog Number : HYP II-11

Device Description : HyProCure II Sinus Tarsi Implant Size 11. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 11. 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HyProCure II Sinus Tarsi Stent Size 12 - M621HYPII120 Catalog Number : HYP II-12

Device Description : HyProCure II Sinus Tarsi Implant Size 12. Indications: HyProCure II (HYP II a HyProCure II Sinus Tarsi Implant Size 12. 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.

Device Class : 2

Duns Number: 828660345

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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