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 - 00810021380315 Catalog Number : 101-0110-N

Device Description : PRE-BENT ROD, ø5.5 X 110

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 - 00810021380322 Catalog Number : 101-0120-N

Device Description : PRE-BENT ROD, ø5.5 X 120

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 - 00810021380339 Catalog Number : 101-0130-N

Device Description : PRE-BENT ROD, ø5.5 X 130

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 - 00810021380346 Catalog Number : 101-0140-N

Device Description : PRE-BENT ROD, ø5.5 X 140

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 - 00810021380353 Catalog Number : 101-0150-N

Device Description : PRE-BENT ROD, ø5.5 X 150

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 - 00810021380360 Catalog Number : 101-0160-N

Device Description : PRE-BENT ROD, ø5.5 X 160

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 - 00810021380377 Catalog Number : 101-0170-N

Device Description : PRE-BENT ROD, ø5.5 X 170

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 - 00810021380384 Catalog Number : 101-0180-N

Device Description : PRE-BENT ROD, ø5.5 X 180

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 - 00810021380421 Catalog Number : PSS-DRIVER-00

Device Description : GMA Pedicle Screw Driver Assembly

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 - 00810021380438 Catalog Number : PSS-DRIVER-12

Device Description : GMA Pedicle Screw Driver Assembly

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

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