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) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10) Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

Clear

GMA 2.0 Pedicle Screw System - 00810021380216 Catalog Number : 101-0035-N

Device Description : PRE-BENT ROD, ø5.5 X 35

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380223 Catalog Number : 101-0040-N

Device Description : PRE-BENT ROD, ø5.5 X 40

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380230 Catalog Number : 101-0045-N

Device Description : PRE-BENT ROD, ø5.5 X 45

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380247 Catalog Number : 101-0050-N

Device Description : PRE-BENT ROD, ø5.5 X 50

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380254 Catalog Number : 101-0055-N

Device Description : PRE-BENT ROD, ø5.5 X 55

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380261 Catalog Number : 101-0060-N

Device Description : PRE-BENT ROD, ø5.5 X 60

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380278 Catalog Number : 101-0070-N

Device Description : PRE-BENT ROD, ø5.5 X 70

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380285 Catalog Number : 101-0080-N

Device Description : PRE-BENT ROD, ø5.5 X 80

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380292 Catalog Number : 101-0090-N

Device Description : PRE-BENT ROD, ø5.5 X 90

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

GMA 2.0 Pedicle Screw System - 00810021380308 Catalog Number : 101-0100-N

Device Description : PRE-BENT ROD, ø5.5 X 100

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

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