ISOTIS ORTHOBIOLOGICS, INC.

Address:2 Goodyear,IRVINE,CA,92618,US

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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

FILLER, BONE VOID, CALCIUM COMPOUND (MQV) (10) Filler, bone void, osteoinduction (w/o human growth factor) (MBP) (10)

Premarket Exempt

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Accell Evo3 Putty - 10889981055394 Catalog Number : 02-5000-025

Device Description : Accell Evo3 Putty, 2.5cc - demineralized human bone mixed with poloxamer resorb Accell Evo3 Putty, 2.5cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MBP, MQV

Prescription Use : Yes

Device Count : 1

Accell Evo3 Putty - 10889981055400 Catalog Number : 02-5000-050

Device Description : Accell Evo3 Putty,5 cc - demineralized human bone mixed with poloxamer resorbab Accell Evo3 Putty,5 cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MBP, MQV

Prescription Use : Yes

Device Count : 1

Accell Evo3 Putty - 10889981055417 Catalog Number : 02-5000-100

Device Description : Accell Evo3 Putty, 10cc - demineralized human bone mixed with poloxamer resorba Accell Evo3 Putty, 10cc - demineralized human bone mixed with poloxamer resorbable reverse phase medium. Accell Evo3 is formulated into a putty form and is provided in a sterile, single use package.

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MQV, MBP

Prescription Use : Yes

Device Count : 1

Accell Evo3 C Putty - 10889981055424 Catalog Number : 02-6000-025

Device Description : Accell Evo3c Putty, 2.5cc - demineralized human bone and cancellous chips mixed Accell Evo3c Putty, 2.5cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Accell Evo3c is formulated into a putty form and is provided in a sterile, single use package

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MQV, MBP

Prescription Use : Yes

Device Count : 1

Accell Evo3 C Putty - 10889981055431 Catalog Number : 02-6000-050

Device Description : Accell Evo3c Putty, 5cc - demineralized human bone and cancellous chips mixed w Accell Evo3c Putty, 5cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Accell Evo3c is formulated into a putty form and is provided in a sterile, single use package

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MQV, MBP

Prescription Use : Yes

Device Count : 1

Accell Evo3 C Putty - 10889981055448 Catalog Number : 02-6000-100

Device Description : Accell Evo3c Putty, 10cc - demineralized human bone and cancellous chips mixed Accell Evo3c Putty, 10cc - demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Accell Evo3c is formulated into a putty form and is provided in a sterile, single use package

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MQV, MBP

Prescription Use : Yes

Device Count : 1

Accell Connexus - 10889981055455 Catalog Number : 02-3000-005

Device Description : Accell Connexus, 0.5cc - demineralized human bone mixed with poloxamer reverse p Accell Connexus, 0.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MBP, MQV

Prescription Use : Yes

Device Count : 1

Accell Connexus - 10889981055462 Catalog Number : 02-3000-010

Device Description : Accell Connexus, 1cc - demineralized human bone mixed with poloxamer reverse pha Accell Connexus, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MQV, MBP

Prescription Use : Yes

Device Count : 1

Accell Connexus - 10889981055479 Catalog Number : 02-3000-025

Device Description : Accell Connexus, 2.5cc - demineralized human bone mixed with poloxamer reverse p Accell Connexus, 2.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MBP, MQV

Prescription Use : Yes

Device Count : 1

Accell Connexus - 10889981055486 Catalog Number : 02-3000-050

Device Description : Accell Connexus, 5cc - demineralized human bone mixed with poloxamer reverse pha Accell Connexus, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is provided in a sterile, single use package

Device Class : 2

Duns Number: 801089152

Premarket Exempt : No

Product Code : MBP, MQV

Prescription Use : Yes

Device Count : 1

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