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 - 10381780009955 Catalog Number : 10-10-8540

Device Description : Fixed Screw 8.50mm 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 - 10381780009962 Catalog Number : 10-10-8545

Device Description : Fixed Screw 8.50mm x 45mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009979 Catalog Number : 10-10-8550

Device Description : Fixed Screw 8.50mm 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 - 10381780009986 Catalog Number : 10-10-8555

Device Description : Fixed Screw 8.50mm x 55mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780009993 Catalog Number : 10-10-8560

Device Description : Fixed Screw 8.50mm x 60mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780010005 Catalog Number : 10-10-8565

Device Description : Fixed Screw 8.50mm x 65mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780010012 Catalog Number : 10-10-8570

Device Description : Fixed Screw 8.50mm 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 - 10381780010029 Catalog Number : 10-10-8575

Device Description : Fixed Screw 8.50mm x 75mm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

Coral - 10381780010036 Catalog Number : 10-10-8580

Device Description : Fixed Screw 8.50mm 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 - 10381780010043 Catalog Number : 10-10-8585

Device Description : Fixed Screw 8.50mm x 85mm

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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