MEDFIX INTERNATIONAL, LLC

Address:5620 North Kolb Road,Tucson,AZ,85750,US

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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

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (5) CURETTE, SURGICAL, GENERAL USE (FZS) (2) RETRACTOR (GAD) (1) SCREWDRIVER (HXX) (1) TRAY, SURGICAL, INSTRUMENT (FSM) (1)

Premarket Exempt

Yes

Clear

Medfix - 00810021830315 Catalog Number :

Device Description : Medfix® Lumbar Top Loading Blade Holder

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Medfix - 00810021830322 Catalog Number :

Device Description : Medfix® Elliptical Lumbar Front Loading Blade Holder

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Medfix - 00810021830339 Catalog Number :

Device Description : Medfix® T-Handle

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Medfix - 00810021830346 Catalog Number :

Device Description : Medfix® Elliptical Lumbar Retractor Frame

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Medfix - 00810021830353 Catalog Number :

Device Description : Medfix® Cervical Distractor (100mm rack) - Left

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Medfix - 00810021830360 Catalog Number :

Device Description : Medfix® Cervical Distractor (100mm rack) - Right

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Medfix - 00810021830377 Catalog Number :

Device Description : Medfix® Distraction Screw Driver 8" (200mm)

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : No

Device Count : 1

Medfix - 00810021830384 Catalog Number :

Device Description : Medfix® Caspar Style Distractor Set Sterilization Case

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830391 Catalog Number :

Device Description : Medfix® MIS Curette, Bayoneted, Silicone Handle, 4.6mm Reverse Angled Cup, Worki Medfix® MIS Curette, Bayoneted, Silicone Handle, 4.6mm Reverse Angled Cup, Working Length 6" (150mm), Total Length 12" (305mm)

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FZS

Prescription Use : No

Device Count : 1

Medfix - 00810021830407 Catalog Number :

Device Description : Medfix® MIS Curette, Bayoneted, Silicone Handle, 7.5mm Reverse Angled Cup, Worki Medfix® MIS Curette, Bayoneted, Silicone Handle, 7.5mm Reverse Angled Cup, Working Length 6" (150mm) Total Length 12" (305mm)

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FZS

Prescription Use : No

Device Count : 1

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