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) (10)

Premarket Exempt

No Yes

Clear

Calvary Spine Pedicle Screw System - B1145500 Catalog Number : 550

Device Description : PreLordosed Rod 5.5mm Diameter 50mm length Ti6Al4V

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B1145600 Catalog Number : 560

Device Description : PreLordosed Rod 5.5mm Diameter 60mm length Ti6Al4V

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B1145700 Catalog Number : 570

Device Description : PreLordosed Rod 5.5mm Diameter 70mm length Ti6Al4V

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B1145800 Catalog Number : 580

Device Description : PreLordosed Rod 5.5mm Diameter 80mm length Ti6Al4V

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B1145900 Catalog Number : 590

Device Description : PreLordosed Rod 5.5mm Diameter 90mm length Ti6Al4V

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B11475300 Catalog Number : 17530

Device Description : Polyaxial Screw 7.5mm 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 - B11475500 Catalog Number : 17550

Device Description : Polyaxial Screw 7.5mm 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 - B11475550 Catalog Number : 17555

Device Description : Polyaxial Screw 7.5mm 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 - B1148300 Catalog Number : 830

Device Description : Illiac Connector 5.5mm Diameter 30mm Rod Length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B1148500 Catalog Number : 850

Device Description : Illiac Connector 5.5mm Diameter 50mm Rod Length

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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