B-ONE ORTHO, CORP.

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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (10) Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate (MEH) (10) Screw, Fixation, Bone (HWC) (10)

Premarket Exempt

No Yes

Clear

b-ONE™ 12/14 Taper Femoral Head - 00843575100009 Catalog Number : 397175445

Device Description : Femoral Head, BIOLOX® delta ceramic; 28mm Diameter, -3.5mm Neck Length

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100023 Catalog Number : 8819042001

Device Description : BROACH, SIZE 1

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100030 Catalog Number : 8819042002

Device Description : BROACH, SIZE 2

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100047 Catalog Number : 8819042003

Device Description : BROACH, SIZE 3

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100054 Catalog Number : 8819042004

Device Description : BROACH, SIZE 4

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100061 Catalog Number : 8819042005

Device Description : BROACH, SIZE 5

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : LZO, MEH, HWC

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100078 Catalog Number : 8819042006

Device Description : BROACH, SIZE 6

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100085 Catalog Number : 8819042007

Device Description : BROACH, SIZE 7

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100092 Catalog Number : 8819042008

Device Description : BROACH, SIZE 8

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100108 Catalog Number : 8819042009

Device Description : BROACH, SIZE 9

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

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