INTELLIGENT IMPLANT SYSTEMS, LLC

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

No

Clear

Revolution - 00814033020009 Catalog Number : 1162530S

Device Description : 25-30mm Straight Connector

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020016 Catalog Number : 1163035C

Device Description : 30-35mm Contoured Connector

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020023 Catalog Number : 1163540C

Device Description : 35-40mm Contoured Connector

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020030 Catalog Number : 1164045C

Device Description : 40-45mm Contoured Connector

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020047 Catalog Number : 1164550C

Device Description : 45-50mm Contoured Connector

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020054 Catalog Number : 1165055C

Device Description : 50-55mm Contoured Connector

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020061 Catalog Number : 11645254

Device Description : 4.5 X 25mm Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020078 Catalog Number : 11645304

Device Description : 4.5 X 30mm Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020085 Catalog Number : 11645354

Device Description : 4.5 X 35mm Bone Screw, 4mm Offset

Device Class : 2

Duns Number: 013742030

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Revolution - 00814033020092 Catalog Number : 11645404

Device Description : 4.5 X 40mm 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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