Kalitec Direct LLC

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Filters

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

Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (3) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (2) Thoracolumbosacral Pedicle Screw System (NKB) (2) Bender (HXW) (1) Rasp (HTR) (1) Tray, Surgical (LRP) (1)

Premarket Exempt

No Yes

Clear

Matira - B073K0730000 Catalog Number : 07-K07-3000

Device Description : Plate Bender, Universal

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HXW

Prescription Use : Yes

Device Count : 1

TiWAVE C Cervical Cage System - B074320CFT32090 Catalog Number :

Device Description : Cervical Cage, flat, 13mm x 12mm, 9mm, 7 degrees, tapered

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Ocata Anterior Cervical System - B078308CPR03511 Catalog Number : 08-CPR-0351

Device Description : Cervical Plate, Three Level, 51mm

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

InTess C Cervical Cage System - B09CCN95050 Catalog Number :

Device Description : Cervical Cage, 19 x 15, 5mm, 0 Degree, No Taper

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

InTess C Cervical Cage System - B09CCT95090 Catalog Number :

Device Description : Cervical Cage, 19 x 15, 9mm, 7 Degree, Tapered

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Ocata Anterior Cervical System - BO7308SDF40131 Catalog Number : 08-SDF-4013

Device Description : Scew, Self Drilling, Fixed, 4.0 x 13mm

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

CosmoLock Pedicle Screw System - BO7310SNE47451 Catalog Number : 10-SNE-4745

Device Description : SCREW, CORTICAL, EXT TAB CANN, 4.75 X 45MM

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

CosmoLock Pedicle Screw System - BO7310SNE47551 Catalog Number : 10-SNE-4755

Device Description : SCREW, CORTICAL, EXT TAB CANN, 4.75 X 55MM

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

TiWAVE L Lumbar Cage System - BO7323K0104000 Catalog Number :

Device Description : Caddie, Trials

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Disc Prep - BO73DRK0100270 Catalog Number : DR-K01-0027

Device Description : Rasp, Angled Lumbar

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HTR

Prescription Use : No

Device Count : 1

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