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

Tray, Surgical (LRP) (5) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (1) Bit, Drill (HTW) (1) Extractor (HWB) (1) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (1) Passer, Wire, Orthopedic (HXI) (1)

Premarket Exempt

No Yes

Clear

Kalitec Universal Instruments - B07301K0620000 Catalog Number : 01-K06-2000

Device Description : Universal Removal Set

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HWB

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K1100000 Catalog Number : 01-K11-0000

Device Description : Tray Lid, Universal Blank, Arcamed

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K1102250 Catalog Number : 01-K11-0225

Device Description : Tray, Base, 2.25", Universal

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K1103500 Catalog Number : 01-K11-0350

Device Description : Tray, Base, 3.5", Arcamed

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K1104250 Catalog Number : 01-K11-0425

Device Description : Tray, Base, 4.25", Arcamed

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K1106000 Catalog Number : 01-K11-0600

Device Description : Tray, Base, 6", Arcamed

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

Kalitec Universal Instruments - B07301K1284520 Catalog Number : 01-K12-8452

Device Description : Tube, Guidewire, 520MM

Device Class : 1

Duns Number: 041956211

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Ocata Anterior Cervical System - B07305SDV40191 Catalog Number : 08-SDV-4019

Device Description : Screw, Self Drilling, Variable, 4.0 x 19mm

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

InTess C Cervical Cage System - B07306CCN41090 Catalog Number :

Device Description : Cervical Cage, 14 x 11, 9mm, 0 Degree, No Taper

Device Class : 2

Duns Number: 041956211

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

MATIRA ANTERIOR CERVICAL SYSTEM - B07307ADD10101 Catalog Number : 07-ADD-1010

Device Description : DRILL, 10 MM, HELICAL, DISPOSABLE

Device Class : 1

Duns Number: 041956211

Premarket Exempt : No

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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