INTELLIGENT IMPLANT SYSTEMS, LLC

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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 Intervertebral Body (KWQ) (8)

Premarket Exempt

Clear

Mediant Anterior Cervical Plate - 00814033021211 Catalog Number :

Device Description : Mediant 4.5 x 10 mm Bone Screw

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Mediant Anterior Cervical Plate - 00814033021228 Catalog Number :

Device Description : Mediant 4.5 x 12 mm Bone Screw

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Mediant Anterior Cervical Plate - 00814033021235 Catalog Number :

Device Description : Mediant 4.5 x 14 mm Bone Screw

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Mediant Anterior Cervical Plate - 00814033021242 Catalog Number :

Device Description : Mediant 4.5 x 16 mm Bone Screw

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Mediant Anterior Cervical Plate - 00814033021259 Catalog Number :

Device Description : Mediant 4.5 x 18 mm Bone Screw

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

MEDIANT - 00814033021266 Catalog Number : 121302

Device Description : Mediant Positioning Pins, Re-usable

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

MEDIANT - 00814033021273 Catalog Number : 121309

Device Description : Mediant 2.0 mm Drill Guide

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

MEDIANT - 00814033021280 Catalog Number : 121308

Device Description : Mediant 2.0 mm Drill

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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