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

Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (10)

Premarket Exempt

Clear

Revolution - 00814033020108 Catalog Number : 11645454

Device Description : 4.5 X 45mm Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020115 Catalog Number : 11645504

Device Description : 4.5 X 50mm Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020122 Catalog Number : 11655254

Device Description : 5.5 X 25mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020139 Catalog Number : 11655304

Device Description : 5.5 X 30mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020146 Catalog Number : 11655354

Device Description : 5.5 X 35mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020153 Catalog Number : 11655404

Device Description : 5.5 X 40mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020160 Catalog Number : 11655454

Device Description : 5.5 X 45mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020177 Catalog Number : 11655504

Device Description : 5.5 X 50mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020184 Catalog Number : 11655554

Device Description : 5.5 X 55mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020191 Catalog Number : 11665254

Device Description : 6.5 X 25mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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