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) (10) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (10)

Premarket Exempt

Clear

Valeo Spacer System - M555916005011 Catalog Number : 91.600.5011

Device Description : Valeo II Dual Convex Cervical Trial, 11mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916005012 Catalog Number : 91.600.5012

Device Description : Valeo II Dual Convex Cervical Trial, 12mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916005013 Catalog Number : 91.600.5013

Device Description : Valeo II Dual Convex Cervical Trial, 13mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916005014 Catalog Number : 91.600.5014

Device Description : Valeo II Dual Convex Cervical Trial, 14mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916006105 Catalog Number : 91.600.6105

Device Description : Valeo II C, 14x12 0° 5-6mm -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 - M555916006107 Catalog Number : 91.600.6107

Device Description : Valeo II C, 14x12 0° 7-8mm -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 - M555916006109 Catalog Number : 91.600.6109

Device Description : Valeo II C, 14x12 0° 9-10mm -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 - M555916006111 Catalog Number : 91.600.6111

Device Description : Valeo II C, 14x12 0° 11-12mm -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 - M555916006113 Catalog Number : 91.600.6113

Device Description : Valeo II C, 14x12 0° 13-14mm -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 - M555916006205 Catalog Number : 91.600.6205

Device Description : Valeo II C, 16x14 0° 5-6mm -0.5 Stop

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

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