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

Cervical Interbody Spacer Trial - B114210070 Catalog Number : 210-07

Device Description : Trial for 7mm standard cervical inter-vertebral body spacer

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer Trial - B114210080 Catalog Number : 210-08

Device Description : Trial for 8mm standard cervical inter-vertebral body spacer

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer Trial - B114210090 Catalog Number : 210-09

Device Description : Trial for 9mm standard cervical inter-vertebral body spacer

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Rasp - B114211000 Catalog Number : 211-00

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 Interbody Spacer Trial - B114211050 Catalog Number : 211-05

Device Description : Dual Head Trial for 5mm standard and large cervical inter-vertebral body spacers

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer Trial - B114211060 Catalog Number : 211-06

Device Description : Dual Head Trial for 6mm standard and large cervical inter-vertebral body spacers

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer Trial - B114211070 Catalog Number : 211-07

Device Description : Dual Head Trial for 7mm standard and large cervical inter-vertebral body spacers

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer Trial - B114211080 Catalog Number : 211-08

Device Description : Dual Head Trial for 8mm standard and large cervical inter-vertebral body spacers

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer Trial - B114211090 Catalog Number : 211-09

Device Description : Dual Head Trial for 9mm standard and large cervical inter-vertebral body spacers

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cervical Tamp - B114212000 Catalog Number : 212-00

Device Description : Tamp 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

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