ELEVATION SPINE, INC.

Address:2511 Garden Road,Monterey,CA,93940,US

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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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (5) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (5) Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) (5)

Premarket Exempt

Clear

Trial Head 15x18x10 9 deg. - 00810017913213 Catalog Number : CI-TH5891

Device Description : Trial Head 15x18x10 9 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

Spike Driver, 5-7mm - 00810017913220 Catalog Number : CI-DRIVER-SP-567

Device Description : Spike Driver, 5-7mm

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

Spike Driver, 8-9mm - 00810017913237 Catalog Number : CI-DRIVER-SP-89

Device Description : Spike Driver, 8-9mm

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

Spike Driver, 10mm - 00810017913244 Catalog Number : CI-DRIVER-SP-10

Device Description : Spike Driver, 10mm

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

Assembly tool - 00810017913251 Catalog Number : CI-BLOCK

Device Description : Assembly tool

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

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