Vivorte, Inc

Address:1044 E Chestnut St,Louisville,KY,40204,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) Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) (MBP) (1)

Premarket Exempt

Clear

Trabexus ® - 00868201000102 Catalog Number : 131133-03

Device Description : Calcium compound bone void filler (3cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Trabexus ® - 00868201000119 Catalog Number : 131133-05

Device Description : Calcium compound bone void filler (5 cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Trabexus ® - 00868201000126 Catalog Number : 131133-10

Device Description : Calcium compound bone void filler (10 cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Wizard CaP - 00868201000133 Catalog Number :

Device Description : Calcium Bone Void Filler (3 cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Wizard CaP - 00868201000140 Catalog Number :

Device Description : Calcium compound bone void filler (5 cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

Wizard CaP - 00868201000157 Catalog Number :

Device Description : Calcium compound bone void filler (10 cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Fortera - 00868201000164 Catalog Number : 131133-03-S

Device Description : Calcium compound bone void filler (3 cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Fortera - 00868201000171 Catalog Number : 131133-05-S

Device Description : Calcium compound bone void filler (5 cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Fortera - 00868201000188 Catalog Number :

Device Description : Calcium compound bone void filler (10 cc)

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Trabexus® - W4146EB0003T0475 Catalog Number : 130703-03

Device Description : Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexu Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand name.

Device Class : 2

Duns Number: 078400984

Premarket Exempt : No

Product Code : MQV, MBP

Prescription Use : Yes

Device Count : 1

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