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

Orthopedic Manual Surgical Instrument (LXH) (5) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (5)

Premarket Exempt

No Yes

Clear

AR Specialty Femoral - 00843575112781 Catalog Number : 8829P00062

Device Description : Femoral Trial - Size 8, Right

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112798 Catalog Number : 8829P00063

Device Description : Femoral Trial - Size 9, Left

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112804 Catalog Number : 8829P00064

Device Description : Femoral Trial - Size 9, Right

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112811 Catalog Number : 8829P00065

Device Description : Femoral Trial - Size 10, Left

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112828 Catalog Number : 8829P00066

Device Description : Femoral Trial - Size 10, Right

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112835 Catalog Number : 8829102500

Device Description : Adjustable Distal Resection Block Tower

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112842 Catalog Number : 8829933001

Device Description : CR Femoral Prep and Trials 3-8 AR Tray

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112859 Catalog Number : 8829933002

Device Description : CR Femoral Prep and Trials 3-8 PR Tray

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112866 Catalog Number : 8829933003

Device Description : CR Femoral Prep and Trials 1-2/9-10 AR Tray

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112873 Catalog Number : 8829933004

Device Description : CR Femoral Prep and Trials 1-2/9-10 PR Tray

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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