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 - 10381780009733 Catalog Number : 10-10-6590

Device Description : Fixed Screw 6.50mm x 90mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009740 Catalog Number : 10-10-6595

Device Description : Fixed Screw 6.50mm x 95mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009764 Catalog Number : 10-10-7525

Device Description : Fixed Screw 7.50mm x 25mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009771 Catalog Number : 10-10-7530

Device Description : Fixed Screw 7.50mm x 30mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009788 Catalog Number : 10-10-7535

Device Description : Fixed Screw 7.50mm x 35mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009795 Catalog Number : 10-10-7540

Device Description : Fixed Screw 7.50mm x 40mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009801 Catalog Number : 10-10-7545

Device Description : Fixed Screw 7.50mm x 45mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009818 Catalog Number : 10-10-7550

Device Description : Fixed Screw 7.50mm 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 - 10381780009825 Catalog Number : 10-10-7555

Device Description : Fixed Screw 7.50mm 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 - 10381780009832 Catalog Number : 10-10-7560

Device Description : Fixed Screw 7.50mm x 60mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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