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

Appliance, Fixation, Spinal Interlaminal (KWP) (10) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (10) Orthosis, Spinal Pedicle Fixation (MNI) (10)

Premarket Exempt

Clear

Preference 2 - M555102100150 Catalog Number : 10-2100-150

Device Description : Straight Rod 6.0mm, 150mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102100250 Catalog Number : 10-2100-250

Device Description : Straight Rod 6.0mm, 250mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102100350 Catalog Number : 10-2100-350

Device Description : Straight Rod 6.0mm, 350mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102100450 Catalog Number : 10-2100-450

Device Description : Straight Rod 6.0mm, 450mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102100600 Catalog Number : 10-2100-600

Device Description : Straight Rod 6.0mm, 600mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200030 Catalog Number : 10-2200-030

Device Description : Straight Rod 6.0mm, 30mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200040 Catalog Number : 10-2200-040

Device Description : Straight Rod 6.0mm, 40mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200050 Catalog Number : 10-2200-050

Device Description : Straight Rod 6.0mm, 50mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200060 Catalog Number : 10-2200-060

Device Description : Straight Rod 6.0mm, 60mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200070 Catalog Number : 10-2200-070

Device Description : Straight Rod 6.0mm, 70mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

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