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) (7) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (3)

Premarket Exempt

No Yes

Clear

MOBIO™ Total Knee System - 00843575112880 Catalog Number : 8829933005

Device Description : CR Insert Trials Tray

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112897 Catalog Number : 8829933006

Device Description : CR PLUS Insert Trials Tray

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112903 Catalog Number : 8829214113

Device Description : Quick Connect Keel Punch Size A-C

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112910 Catalog Number : 8829214147

Device Description : Quick Connect Keel Punch Size D-G

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112927 Catalog Number : 8829214189

Device Description : Quick Connect Keel Punch Size H-J

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112934 Catalog Number : 8829211002

Device Description : Spacer Block, Size BC, 9/10mm

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112941 Catalog Number : 8829211012

Device Description : Spacer Block, Size BC, 11/13mm

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112958 Catalog Number : 8829211022

Device Description : Spacer Block, Size BC, 16/19mm

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112965 Catalog Number : 8829211032

Device Description : Spacer Block, Size BC, 22/25mm

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MOBIO™ Total Knee System - 00843575112972 Catalog Number : 8829211042

Device Description : Spacer Block, Size BC, 12/14mm

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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