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 - 00810021380018 Catalog Number : 601-5530-D

Device Description : Polyaxial Pedicle Screw Assembly, 5.5 X 30, Dual Lead, Non-Cannulated

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 - 00810021380025 Catalog Number : 601-5535-D

Device Description : Polyaxial Pedicle Screw Assembly, 5.5 X 35, Dual Lead, Non-Cannulated

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 - 00810021380032 Catalog Number : 601-5540-D

Device Description : Polyaxial Pedicle Screw Assembly, 5.5 X 40, Dual Lead, Non-Cannulated

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 - 00810021380049 Catalog Number : 601-5545-D

Device Description : Polyaxial Pedicle Screw Assembly, 5.5 X 45, 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 - 00810021380056 Catalog Number : 601-5550-D

Device Description : Polyaxial Pedicle Screw Assembly, 5.5 X 50, 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 - 00810021380063 Catalog Number : 601-5555-D

Device Description : Polyaxial Pedicle Screw Assembly, 5.5 X 55, 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 - 00810021380070 Catalog Number : 601-6535-D

Device Description : Polyaxial Pedicle Screw Assembly, 6.5 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 - 00810021380087 Catalog Number : 601-6540-D

Device Description : Polyaxial Pedicle Screw Assembly, 6.5 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 - 00810021380094 Catalog Number : 601-6545-D

Device Description : Polyaxial Pedicle Screw Assembly, 6.5 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 - 00810021380100 Catalog Number : 601-6550-D

Device Description : Polyaxial Pedicle Screw Assembly, 6.5 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

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