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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (9) Thoracolumbosacral Pedicle Screw System (NKB) (1)

Premarket Exempt

No Yes

Clear

Lumbar Interbody Spacer - B114100070 Catalog Number : 100-07

Device Description : 7mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer Crescent - B114100080 Catalog Number : 100-08

Device Description : 8mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer - B114100090 Catalog Number : 100-09

Device Description : 9mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Calvary Spine Pedicle Screw System - B11410010 Catalog Number : 1001

Device Description : Locking Cap

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer - B114100100 Catalog Number : 100-10

Device Description : 10mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer - B114100110 Catalog Number : 100-11

Device Description : 11mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer - B114100120 Catalog Number : 100-12

Device Description : 12mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer - B114100130 Catalog Number : 100-13

Device Description : 13mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer - B114100140 Catalog Number : 100-14

Device Description : 14mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer - B114100150 Catalog Number : 100-15

Device Description : 15mm Lumbar PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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