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

TRAY, SURGICAL, INSTRUMENT (FSM) (6) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (4)

Premarket Exempt

Yes

Clear

Medfix - 00810021830612 Catalog Number :

Device Description : Medfix® MDS Microdiscectomy System Insert #2

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830629 Catalog Number :

Device Description : Medfix® Vision Anterior Lumbar Insert #1

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830636 Catalog Number :

Device Description : Medfix® Vision Anterior Lumbar Insert #2

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830643 Catalog Number :

Device Description : Medfix® Vision Lumbar Retractor Insert

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830650 Catalog Number :

Device Description : Medfix® Vision Cervical Blade Insert

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830667 Catalog Number :

Device Description : Medfix® Bayoneted Lumbar Curette Set Insert

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Medfix - 00810021830674 Catalog Number :

Device Description : Medfix® Rigid Articulating Arm, L-Column, Square QC Adaptor

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021830681 Catalog Number :

Device Description : Medfix® Retractor Clamp, Square QC Fitting

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021830698 Catalog Number :

Device Description : Medfix® Rotatable Table Clamp

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Medfix - 00810021830704 Catalog Number :

Device Description : Medfix® Instrument C-Clamp, Square QC Fitting

Device Class : 1

Duns Number: 079699357

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

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