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 - 10381780009849 Catalog Number : 10-10-7565

Device Description : Fixed Screw 7.50mm 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 - 10381780009856 Catalog Number : 10-10-7570

Device Description : Fixed Screw 7.50mm x 70mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009863 Catalog Number : 10-10-7575

Device Description : Fixed Screw 7.50mm x 75mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009870 Catalog Number : 10-10-7580

Device Description : Fixed Screw 7.50mm x 80mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009887 Catalog Number : 10-10-7585

Device Description : Fixed Screw 7.50mm x 85mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009894 Catalog Number : 10-10-7590

Device Description : Fixed Screw 7.50mm x 90mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009900 Catalog Number : 10-10-7595

Device Description : Fixed Screw 7.50mm x 95mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009924 Catalog Number : 10-10-8525

Device Description : Fixed Screw 8.50mm x 25mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009931 Catalog Number : 10-10-8530

Device Description : Fixed Screw 8.50mm 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 - 10381780009948 Catalog Number : 10-10-8535

Device Description : Fixed Screw 8.50mm x 35mm

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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