AMEDICA CORPORATION

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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) (5) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (4)

Premarket Exempt

Clear

Valeo Spacer System - M555916006707 Catalog Number : 91.600.6707

Device Description : Valeo II C, 16x14 6° 7-8mm -0.5 Stop

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916006709 Catalog Number : 91.600.6709

Device Description : Valeo II C, 16x14 6° 9-10mm -0.5 Stop

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916006711 Catalog Number : 91.600.6711

Device Description : Valeo II C, 16x14 6° 11-12mm -0.5 Stop

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916006713 Catalog Number : 91.600.6713

Device Description : Valeo II C, 16x14 6° 13-14mm -0.5 Stop

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555999999999 Catalog Number : 11.009.1605

Device Description : VALEO Z 99x99mm x 99mm height 6º Lordosis, textured

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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