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 - M555102200080 Catalog Number : 10-2200-080

Device Description : Straight Rod 6.0mm, 80mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200090 Catalog Number : 10-2200-090

Device Description : Straight Rod 6.0mm, 90mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200100 Catalog Number : 10-2200-100

Device Description : Straight Rod 6.0mm, 100mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200110 Catalog Number : 10-2200-110

Device Description : Straight Rod 6.0mm, 110mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200120 Catalog Number : 10-2200-120

Device Description : Straight Rod 6.0mm, 120mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200130 Catalog Number : 10-2200-130

Device Description : Straight Rod 6.0mm, 130mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : KWQ, KWP, MNI

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200140 Catalog Number : 10-2200-140

Device Description : Straight Rod 6.0mm, 140mm

Device Class : 2

Duns Number: 028629553

Premarket Exempt : No

Product Code : MNI, KWP, KWQ

Prescription Use : Yes

Device Count : 1

Preference 2 - M555102200150 Catalog Number : 10-2200-150

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 - M555102200250 Catalog Number : 10-2200-250

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 - M555102200350 Catalog Number : 10-2200-350

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

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