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) (7) Orthopedic Manual Surgical Instrument (LXH) (3)

Premarket Exempt

No Yes

Clear

Lumbar Interbody Spacer Trial - B114310130 Catalog Number : 310-13

Device Description : Trial for 13mm straight lumbar inter-vertebral body spacer

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer Trial - B114310140 Catalog Number : 310-14

Device Description : Trial for 14mm straight lumbar inter-vertebral body spacer

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer Trial - B114310150 Catalog Number : 310-15

Device Description : Trial for 15mm straight lumbar inter-vertebral body spacer

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B11451000 Catalog Number : 5100

Device Description : PreLordosed Rod 5.5mm Diameter 100mm 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 - B11452400 Catalog Number : 5240

Device Description : PreLordosed Rod 5.5mm Diameter 240mm 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 - B1145300 Catalog Number : 530

Device Description : PreLordosed Rod 5.5mm Diameter 30mm 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 - B1145350 Catalog Number : 535

Device Description : PreLordosed Rod 5.5mm Diameter 35mm 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 - B1145400 Catalog Number : 540

Device Description : PreLordosed Rod 5.5mm Diameter 40mm 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 - B1145450 Catalog Number : 545

Device Description : PreLordosed Rod 5.5mm Diameter 45mm 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 - B11454800 Catalog Number : 5480

Device Description : Straight Rod 5.5mm Diameter 480mm length Ti6Al4V

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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