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) (2) Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) (MBP) (2)

Premarket Exempt

Clear

Trabexus® - W4146EB0005T0475 Catalog Number : 130703-05

Device Description : Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus Calcium compound bone void filler with DBM (5cc), 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

Trabexus® - W4146EB0010T0475 Catalog Number : 130703-10

Device Description : Calcium compound bone void filler with DBM (10 cc), previously sold under Trabex Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.