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

Orthopedic Manual Surgical Instrument (LXH) (10)

Premarket Exempt

No Yes

Clear

Lumbar Interbody Spacer Trial - B114110070 Catalog Number : 110-07

Device Description : Trial for 7mm crescent 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 - B114110080 Catalog Number : 110-08

Device Description : Trial for 8mm crescent 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 - B114110090 Catalog Number : 110-09

Device Description : Trial for 9mm crescent 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 - B114110100 Catalog Number : 110-10

Device Description : Trial for 10mm crescent 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 - B114110110 Catalog Number : 110-11

Device Description : Trial for 11mm crescent 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 - B114110120 Catalog Number : 110-12

Device Description : Trial for 12mm crescent 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 - B114110130 Catalog Number : 110-13

Device Description : Trial for 13mm crescent 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 - B114110140 Catalog Number : 110-14

Device Description : Trial for 14mm crescent 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 - B114110150 Catalog Number : 110-15

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

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lumbar Trial Spacer Inserter - B11411500 Catalog Number : 115-00

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

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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