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 - 00810021380117 Catalog Number : 601-6555-D

Device Description : Polyaxial Pedicle Screw Assembly, 6.5 X 55, Dual Lead, Non-Cannulated

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 - 00810021380124 Catalog Number : 601-6560-D

Device Description : Polyaxial Pedicle Screw Assembly, 6.5 X 60, Dual Lead, Non-Cannulated

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 - 00810021380131 Catalog Number : 601-7535-D

Device Description : Polyaxial Pedicle Screw Assembly, 7.5 X 35, Dual Lead, Non-Cannulated

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 - 00810021380148 Catalog Number : 601-7540-D

Device Description : Polyaxial Pedicle Screw Assembly, 7.5 X 40, Dual Lead, Non-Cannulated

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 - 00810021380155 Catalog Number : 601-7545-D

Device Description : Polyaxial Pedicle Screw Assembly, 7.5 X 45, Dual Lead, Non-Cannulated

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 - 00810021380162 Catalog Number : 601-7550-D

Device Description : Polyaxial Pedicle Screw Assembly, 7.5 X 50, Dual Lead, Non-Cannulated

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 - 00810021380179 Catalog Number : 601-7555-D

Device Description : Polyaxial Pedicle Screw Assembly, 7.5 X 55, Dual Lead, Non-Cannulated

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 - 00810021380186 Catalog Number : 601-7560-D

Device Description : Polyaxial Pedicle Screw Assembly, 7.5 X 60, Dual Lead, Non-Cannulated

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 - 00810021380193 Catalog Number : 005-5670

Device Description : LOCKING SCREW / SET SCREW

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 - 00810021380209 Catalog Number : 101-0030-N

Device Description : PRE-BENT ROD, ø5.5 X 30

Device Class : 2

Duns Number: 063381119

Premarket Exempt : No

Product Code : MNH, NKB, MNI

Prescription Use : Yes

Device Count : 1

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