NOVABONE PRODUCTS, LLC

Address:13510 NW US Highway 441,ALACHUA,FL,32615,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

Filler, Bone Void, Calcium Compound (MQV) (10)

Premarket Exempt

Clear

IRM - 15.0cc - 00813909011677 Catalog Number : NP0615

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

IRM MacroPor - 1.6cc - 00813909011691 Catalog Number : NP2501

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

IRM MacroPor - 2.6cc - 00813909011707 Catalog Number : NP2502

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

IRM MacroPor 5.0cc - 00813909011714 Catalog Number : NP2505

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

IRM MacroPor - 8.0cc - 00813909011721 Catalog Number : NP2508

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

IRM MacroPor - 10.0cc - 00813909011738 Catalog Number : NP2510

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

IRM MacroPor - 15.0cc - 00813909011745 Catalog Number : NP2515

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

IRM MIS Cartridge - 5.0cc - 00813909011769 Catalog Number : NP6650

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Particulate 1.0cc - 00813909011943 Catalog Number : NB0701

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Putty MIS System 15.0cc - 00813909011950 Catalog Number :

Device Description : Synthetic bone void filler for orthopedic applications

Device Class : 2

Duns Number: 828813290

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

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