ELEVATION SPINE, INC.

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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (10) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (10) Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE) (10)

Premarket Exempt

Clear

Spikes - 00810017910106 Catalog Number : C-SPIKE-9

Device Description : Saber-C Spikes, 9mm

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

Spikes - 00810017910113 Catalog Number : C-SPIKE-10

Device Description : Saber-C Spikes, 10mm

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

"12(w) x 15(d) Saber-C Bodies (PEEK) " - 00810017910120 Catalog Number : CBP-2505

Device Description : Saber-C Body (P), 12x15x5 0 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

"12(w) x 15(d) Saber-C Bodies (PEEK) " - 00810017910137 Catalog Number : CBP-2506

Device Description : Saber-C Body (P), 12x15x6 0 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

"12(w) x 15(d) Saber-C Bodies (PEEK) " - 00810017910144 Catalog Number : CBP-2507

Device Description : Saber-C Body (P), 12x15x7 0 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

"12(w) x 15(d) Saber-C Bodies (PEEK) " - 00810017910151 Catalog Number : CBP-2508

Device Description : Saber-C Body (P), 12x15x8 0 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

"12(w) x 15(d) Saber-C Bodies (PEEK) " - 00810017910168 Catalog Number : CBP-2509

Device Description : Saber-C Body (P), 12x15x9 0 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

"12(w) x 15(d) Saber-C Bodies (PEEK) " - 00810017910175 Catalog Number : CBP-2501

Device Description : Saber-C Body (P), 12x15x10 0 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

"12(w) x 15(d) Saber-C Bodies (PEEK) " - 00810017910182 Catalog Number : CBP-2565

Device Description : Saber-C Body (P), 12x15x5 6 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

"12(w) x 15(d) Saber-C Bodies (PEEK) " - 00810017910199 Catalog Number : CBP-2566

Device Description : Saber-C Body (P), 12x15x6 6 deg.

Device Class : 2

Duns Number: 085718404

Premarket Exempt : No

Product Code : ODP, OVE, KWQ

Prescription Use : Yes

Device Count : 1

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