AMEDICA CORPORATION

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) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (8)

Premarket Exempt

No

Clear

Preference 2 - M555102000030 Catalog Number : 10-2000-030

Device Description : Curved Rod 6.0mm, 30mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNH, KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102000035 Catalog Number : 10-2000-035

Device Description : Curved Rod 6.0mm, 35mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNH, MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102000040 Catalog Number : 10-2000-040

Device Description : Curved Rod 6.0mm, 40mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNH, KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102000045 Catalog Number : 10-2000-045

Device Description : Curved Rod 6.0mm, 45mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102000050 Catalog Number : 10-2000-050

Device Description : Curved Rod 6.0mm, 50mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNH, KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102000055 Catalog Number : 10-2000-055

Device Description : Curved Rod 6.0mm, 55mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNH, MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102000060 Catalog Number : 10-2000-060

Device Description : Curved 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 - M555102000065 Catalog Number : 10-2000-065

Device Description : Curved Rod 6.0mm, 65mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNH, MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102000070 Catalog Number : 10-2000-070

Device Description : Curved Rod 6.0mm, 70mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNH, KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102000075 Catalog Number : 10-2000-075

Device Description : Curved Rod 6.0mm, 75mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNH, MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

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