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 - 00814033020207 Catalog Number : 11665304

Device Description : 6.5 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 - 00814033020214 Catalog Number : 11665354

Device Description : 6.5 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 - 00814033020221 Catalog Number : 11665404

Device Description : 6.5 X40mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020238 Catalog Number : 11665454

Device Description : 6.5 X45mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020245 Catalog Number : 11665504

Device Description : 6.5 X50mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020252 Catalog Number : 11665554

Device Description : 6.5 X55mm Cannulated Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020269 Catalog Number : 11675254

Device Description : 7.5 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 - 00814033020276 Catalog Number : 11675304

Device Description : 7.5 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 - 00814033020283 Catalog Number : 11675354

Device Description : 7.5 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 - 00814033020290 Catalog Number : 11675404

Device Description : 7.5 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

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