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 - 00810005660105 Catalog Number :

Device Description : Cann. Headed Screw 2.0mmD, 30mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.0mmD, 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 - 00810005660112 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 14mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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 - 00810005660129 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 10mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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 - 00810005660136 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 12mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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 - 00810005660143 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 16mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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 - 00810005660150 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 18mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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 - 00810005660167 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 20mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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 - 00810005660174 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 22mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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 - 00810005660181 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 24mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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 - 00810005660198 Catalog Number :

Device Description : Cann. Headed Screw 2.5mmD, 26mmL The HEALIX Compression Screw (HCS) System is i Cann. Headed Screw 2.5mmD, 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

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