CALVARY SPINE, LLC

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

Thoracolumbosacral Pedicle Screw System (NKB) (9) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Calvary Spine Pedicle Screw System - B114165350 Catalog Number : 16535

Device Description : Polyaxial Screw 6.5mm 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 - B114165400 Catalog Number : 16540

Device Description : Polyaxial Screw 6.5mm Diameter 40mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114165450 Catalog Number : 16545

Device Description : Polyaxial Screw 6.5mm Diameter, 45mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114165500 Catalog Number : 16550

Device Description : Polyaxial Screw 6.5mm 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 - B114165550 Catalog Number : 16555

Device Description : Polyaxial Screw 6.5mm 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 - B114165600 Catalog Number : 16560

Device Description : Polyaxial Screw 6.5mm 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 - B114175400 Catalog Number : 17540

Device Description : Polyaxial Screw 7.5mm Diameter 40mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114175450 Catalog Number : 17545

Device Description : Polyaxial Screw 7.5mm Diameter 45mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114175600 Catalog Number : 17560

Device Description : Polyaxial Screw 7.5mm Diameter 60mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Lumbar Site Prep Set - B114185000 Catalog Number : 185-00

Device Description : Lumbar inter-vertebral body spacers site prep instrument set

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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