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) (5) Orthopedic Manual Surgical Instrument (LXH) (5)

Premarket Exempt

No Yes

Clear

Cervical Spacer Inserter - B114213000 Catalog Number : 213-00

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

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Mallet - B114214000 Catalog Number : 214-00

Device Description : Mallet used for cervical inter-vertebral body spacer placement

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Double Sided Rasp - B114215000 Catalog Number : 215-00

Device Description : Bone Rasp used for site prep for cervical inter-vertebral body spacers

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Implant Caddy - B114280010 Catalog Number : 280-01

Device Description : Sterilization container for Calvary Cervical implants

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Instrument Tray - B114285010 Catalog Number : 285-01

Device Description : Sterilization container for Calvary Cervical instruments

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lumbar Interbody Spacer - B114300070 Catalog Number : 300-07

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 - B114300080 Catalog Number : 300-08

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 - B114300090 Catalog Number : 300-09

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

Lumbar Interbody Spacer - B114300100 Catalog Number : 300-10

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 - B114300110 Catalog Number : 300-11

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

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