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 - 00810005660402 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 22mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 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 - 00810005660419 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 24mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 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 - 00810005660426 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 26mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 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 - 00810005660433 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 28mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 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

Healix - 00810005660440 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 30mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 30mmL 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 - 00810005660457 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 32mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 32mmL 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 - 00810005660464 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 34mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 34mmL 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 - 00810005660471 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 36mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 36mmL 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 - 00810005660488 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 38mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 38mmL 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 - 00810005660495 Catalog Number :

Device Description : Cann. Headed Screw 3.5mmD, 40mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 3.5mmD, 40mmL 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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