INTEGRA LIFESCIENCES CORPORATION

Address:105 and 109 MORGAN LANE,PLAINSBORO,NJ,08536,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 - 10381780009528 Catalog Number : 10-10-5535

Device Description : Fixed Screw 5.50mm 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 - 10381780009535 Catalog Number : 10-10-5540

Device Description : Fixed Screw 5.50mm 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 - 10381780009542 Catalog Number : 10-10-5545

Device Description : Fixed Screw 5.50mm 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 - 10381780009559 Catalog Number : 10-10-5550

Device Description : Fixed Screw 5.50mm x 50mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009566 Catalog Number : 10-10-5555

Device Description : Fixed Screw 5.50mm x 55mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009573 Catalog Number : 10-10-5560

Device Description : Fixed Screw 5.50mm x 60mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009580 Catalog Number : 10-10-5565

Device Description : Fixed Screw 5.50mm x 65mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009603 Catalog Number : 10-10-6525

Device Description : Fixed Screw 6.50mm x 25mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009610 Catalog Number : 10-10-6530

Device Description : Fixed Screw 6.50mm x 30mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009627 Catalog Number : 10-10-6535

Device Description : Fixed Screw 6.50mm x 35mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

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