NVISION BIOMEDICAL TECHNOLOGIES, INC.

Address:4590 Lockhill Selma,San Antonio,TX,78249,US

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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

Clear

Healix - 00810005660006 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 10mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 10mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660013 Catalog Number :

Device Description : Cannulated Headed Screw 2.0mmD, 12mml. The HEALIX Compression Screw (HCS) Syste Cannulated Headed Screw 2.0mmD, 12mml. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660020 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 14mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 14mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660037 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 16mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 16mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660044 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 18mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 18mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660051 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 20mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 20mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660068 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 24mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 24mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660075 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 22mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 22mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660082 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 26mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 26mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Healix - 00810005660099 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 28mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 28mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.

Device Class : 2

Duns Number: 047486041

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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