Maxim Surgical

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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

Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (3)

Premarket Exempt

Clear

Cervical Interbody Fusion Device - B565CT17101 Catalog Number : CT1710

Device Description : Cervical Trial 17x10 mm w/Stop

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565FP20011 Catalog Number : FP2001

Device Description : Final Positioner

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Cervical Interbody Fusion Device - B565MF2004C011 Catalog Number : MF2004c-01

Device Description : Sterilization Tray

Device Class : 2

Duns Number: 012241561

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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