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, Cervical (ODP) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

Cervical Interbody Spacer - B114200070 Catalog Number : 200-07

Device Description : 7mm Cervical PEEK intervertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114200080 Catalog Number : 200-08

Device Description : 8mm Cervical PEEK intervertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114200090 Catalog Number : 200-09

Device Description : 9mm Cervical PEEK intervertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114201050 Catalog Number : 201-05

Device Description : 5mm Cervical PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114201060 Catalog Number : 201-06

Device Description : 6mm Cervical PEEK inter-vertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114201070 Catalog Number : 201-07

Device Description : 7mm Cervical PEEK intervertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114201080 Catalog Number : 201-08

Device Description : 8mm Cervical PEEK intervertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer - B114201090 Catalog Number : 201-09

Device Description : 9mm Cervical PEEK intervertebral body spacer

Device Class : 2

Duns Number: 832116532

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Spacer Trial - B114210050 Catalog Number : 210-05

Device Description : Trial for 5mm 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 - B114210060 Catalog Number : 210-06

Device Description : Trial for 6mm standard cervical inter-vertebral body spacer

Device Class : 1

Duns Number: 832116532

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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