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

Lumbar Spacer Inserter - B114120000 Catalog Number : 120-00

Device Description : Inserter used for lumbar inter-vertebral body spacer placement

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114155250 Catalog Number : 15525

Device Description : Polyaxial Screw 5.5mm Diameter 25 mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114155300 Catalog Number : 15530

Device Description : Polyaxial Screw 5.5mm 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 - B114155350 Catalog Number : 15545

Device Description : Polyaxial Screw 5.5mm 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 - B114155400 Catalog Number : 15540

Device Description : Polyaxial Screw 5.5mm 40 mm Length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B114155450 Catalog Number : 15545

Device Description : Polyaxial Screw 5.5mm 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 - B114155500 Catalog Number : 15550

Device Description : Polyaxial Screw 5.5mm 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 - B114155550 Catalog Number : 15555

Device Description : Polyaxial Screw 5.5mm 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 - B114155600 Catalog Number : 15560

Device Description : Polyaxial Screw 5.5mm 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 - B114165300 Catalog Number : 16530

Device Description : Polyaxial Screw 6.5mm Diameter 30mm length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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