Maxim Surgical

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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

Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (10)

Premarket Exempt

Clear

Cervical Interbody Fusion Device - B5651790400011 Catalog Number : 179-040-001

Device Description : Caddy Tray Small Implants

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B5651790400021 Catalog Number : 179-040-002

Device Description : Caddy Tray Large Implants

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565CI10011 Catalog Number : CI1001

Device Description : Implant Inserter

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565CR1517051 Catalog Number : CR1517-05

Device Description : Cervical RASP 5 mm

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565CR1517061 Catalog Number : CR1517-06

Device Description : Cervical RASP 6 mm

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565CR1517071 Catalog Number : CR1517-07

Device Description : Cervical RASP 7 mm

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565CR1517081 Catalog Number : CR1517-08

Device Description : Cervical RASP 8 mm

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565CR1517091 Catalog Number : CR1517-09

Device Description : Cervical RASP 9 mm

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565CR1517101 Catalog Number : CR1517-10

Device Description : Cervical RASP 10 mm

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565CT150501 Catalog Number : CT1505-0

Device Description : Cervical Trial 15x5 mm No Stop

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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