CALVARY SPINE, LLC

Address:308 North Wind Rd.,Towson,MD,21204,US

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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

Thoracolumbosacral Pedicle Screw System (NKB) (8) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (2)

Premarket Exempt

No Yes

Clear

Calvary Spine Pedicle Screw System - B114185300 Catalog Number : 18530

Device Description : Polyaxial Screw 8.5mm Diameter 30mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B11418535 Catalog Number : 18535

Device Description : Polyaxial Screw 8.5mm Diameter 35mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114185500 Catalog Number : 18550

Device Description : Polyaxial Screw 8.5mm Diameter 50mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114185550 Catalog Number : 18555

Device Description : Polyaxial Screw 8.5mm Diameter 55mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114185600 Catalog Number : 18560

Device Description : Polyaxial Screw 8.5mm Diameter 60mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114185700 Catalog Number : 18570

Device Description : Polyaxial Screw 8.5mm Diameter 70mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114185800 Catalog Number : 18580

Device Description : Polyaxial Screw 8.5mm Diameter 80mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114185900 Catalog Number : 18590

Device Description : Polyaxial Screw 8.5mm Diameter 90mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114200050 Catalog Number : 200-05

Device Description : 5mm Cervical PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114200060 Catalog Number : 200-06

Device Description : 6mm Cervical PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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