AVITUS ORTHOPAEDICS, INC.

Address:6 Armstrong Rd., Suite 107,Shelton,CT,06484,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

Instrument, Biopsy (KNW) (5)

Premarket Exempt

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Avitus Bone Harvester - 00857373006005 Catalog Number : BH8

Device Description : A manual surgical instrument that cuts cancellous bone by manual actuation of th A manual surgical instrument that cuts cancellous bone by manual actuation of the8mm cutting tip. The cap contains a barbed nozzle that connects to standard sized suction tubing (tube with an IDof 6–10 mm) to connect to a vacuum source, wherein the vacuum source has a static maximum pressurebetween 150 mmHg and 300 mmHg. The proposed device can be connected to a waste canister that leads tostandard operating room wall suction or to an external pump. With the device connected to a vacuumsource, when actuated in bone the cutting tip carves, scrapes and cuts cancellous bone and collects the bonegraft inside the handle. The suction pulls the bone and bone marrow from the cutting tip and into the bonereservoir inside the handle. The cap contains a filter that prevents material from escaping the handle into thesuction system by utilizing a physical sieve to keep bone particulate in the handle. After harvesting, the bonegraft can be retrieved from the handle.

Device Class : 2

Duns Number: 078269403

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Avitus Bone Harvester - 00857373006029 Catalog Number : FI-100

Device Description : Filter Accessory for REF: BH8 ONLY

Device Class : 2

Duns Number: 078269403

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Avitus Bone Harvester - 00857373006036 Catalog Number : BH-210

Device Description : Sterile, disposable surgical instrument with 5mm cutting tip for large volume, c Sterile, disposable surgical instrument with 5mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.

Device Class : 2

Duns Number: 078269403

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Avitus Bone Harvester - 00857373006050 Catalog Number : BH-110

Device Description : Sterile, disposable surgical instrument with 8mm cutting tip for large volume, c Sterile, disposable surgical instrument with 8mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.

Device Class : 2

Duns Number: 078269403

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Avitus Bone Harvester - 00857373006074 Catalog Number : BH-220

Device Description : Sterile, disposable surgical instrument with 6mm cutting tip for large volume, c Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow separation insert.

Device Class : 2

Duns Number: 078269403

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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