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 - M555916004610 Catalog Number : 91.600.4610

Device Description : Valeo II 6° 10mm Dual Cervical Trial

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916004611 Catalog Number : 91.600.4611

Device Description : Valeo II 6° 11mm Dual Cervical Trial

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916004612 Catalog Number : 91.600.4612

Device Description : Valeo II 6° 12mm Dual Cervical Trial

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916004613 Catalog Number : 91.600.4613

Device Description : Valeo II 6° 13mm Dual Cervical Trial

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916004614 Catalog Number : 91.600.4614

Device Description : Valeo II 6° 14mm Dual Cervical Trial

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916005006 Catalog Number : 91.600.5006

Device Description : Valeo II Dual Convex Cervical Trial, 6mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916005007 Catalog Number : 91.600.5007

Device Description : Valeo II Dual Convex Cervical Trial, 7mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916005008 Catalog Number : 91.600.5008

Device Description : Valeo II Dual Convex Cervical Trial, 8mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916005009 Catalog Number : 91.600.5009

Device Description : Valeo II Dual Convex Cervical Trial, 9mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : ODP, MAX

Prescription Use : No

Device Count : 1

Valeo Spacer System - M555916005010 Catalog Number : 91.600.5010

Device Description : Valeo II Dual Convex Cervical Trial, 10mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : No

Device Count : 1

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