B-ONE ORTHO, CORP.

Address:3 Wing Drive Suite #259,Cedar Knolls,NJ,07927,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

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (10)

Premarket Exempt

No Yes

Clear

MOBIO™ Total Knee System - 00843575100412 Catalog Number : 8829109051

Device Description : PS Femoral Trial - Size 5/5N, Left

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100429 Catalog Number : 8829109052

Device Description : PS Femoral Trial - Size 5/5N, Right

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100436 Catalog Number : 8829109061

Device Description : PS Femoral Trial - Size 6/6N, Left

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100443 Catalog Number : 8829109062

Device Description : PS Femoral Trial - Size 6/6N, Right

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100450 Catalog Number : 8829109071

Device Description : PS Femoral Trial - Size 7/7N, Left

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100467 Catalog Number : 8829109072

Device Description : PS Femoral Trial - Size 7/7N, Right

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100474 Catalog Number : 8829109081

Device Description : PS Femoral Trial - Size 8, Left

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100481 Catalog Number : 8829109082

Device Description : PS Femoral Trial - Size 8, Right

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100498 Catalog Number : 8829109091

Device Description : PS Femoral Trial - Size 9, Left

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575100504 Catalog Number : 8829109092

Device Description : PS Femoral Trial - Size 9, Right

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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