INTEGRA LIFESCIENCES CORPORATION

INTEGRA LIFESCIENCES CORPORATION

Address:4900 CHARLEMAR DR.,,CINCINNATI,OH,45227,US

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

Premarket Exempt

No Yes

Clear

Coral - 10381780009306 Catalog Number : 10-10-4025

Device Description : Fixed Screw 4.00mm x 25mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : NKB, KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

Coral - 10381780009313 Catalog Number : 10-10-4030

Device Description : Fixed Screw 4.00mm x 30mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : MNI, MNH, KWQ, KWP, NKB

Prescription Use : Yes

Device Count : 1

Coral - 10381780009320 Catalog Number : 10-10-4035

Device Description : Fixed Screw 4.00mm x 35mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : NKB, KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

Coral - 10381780009337 Catalog Number : 10-10-4040

Device Description : Fixed Screw 4.00mm x 40mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : MNI, MNH, KWQ, KWP, NKB

Prescription Use : Yes

Device Count : 1

Coral - 10381780009344 Catalog Number : 10-10-4045

Device Description : Fixed Screw 4.00mm x 45mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : NKB, KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

Coral - 10381780009351 Catalog Number : 10-10-4050

Device Description : Fixed Screw 4.00mm x 50mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : MNI, MNH, KWQ, KWP, NKB

Prescription Use : Yes

Device Count : 1

Coral - 10381780009368 Catalog Number : 10-10-4055

Device Description : Fixed Screw 4.00mm x 55mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : NKB, KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

Coral - 10381780009375 Catalog Number : 10-10-4060

Device Description : Fixed Screw 4.00mm x 60mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : MNI, MNH, KWQ, KWP, NKB

Prescription Use : Yes

Device Count : 1

Coral - 10381780009382 Catalog Number : 10-10-4065

Device Description : Fixed Screw 4.00mm x 65mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : NKB, KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

Coral - 10381780009405 Catalog Number : 10-10-4525

Device Description : Fixed Screw 4.75mm x 25mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : NKB, MNI, MNH, KWQ, KWP

Prescription Use : Yes

Device Count : 1

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