GRAFTON MEDICAL ALLIANCE, INC.

Address:241 South Frontage RD,Burr Ridge,IL,60527,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

Orthosis, Spinal Pedicle Fixation (MNI) (3) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (3) Thoracolumbosacral Pedicle Screw System (NKB) (3)

Premarket Exempt

Clear

GMA 2.0 Pedicle Screw System - 00810021380445 Catalog Number : PSS-INSTRAY1-00

Device Description : INSTRUMENT TRAY #1

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380452 Catalog Number : PSS-INSTRAY2-00

Device Description : INSTRUMENT TRAY #2

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380469 Catalog Number : PSS-IMPTRAY-00

Device Description : IMPLANT TRAY

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : NKB, MNH, MNI

Prescription Use : Yes

Device Count : 1

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