B-ONE ORTHO, CORP.

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

Want to know more about this Organization? Request more information now!

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

Juveno™ Femoral Hip System - 00843575100115 Catalog Number : 8819042010

Device Description : BROACH, SIZE 10

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

Juveno™ Femoral Hip System - 00843575100122 Catalog Number : 8819042011

Device Description : BROACH, SIZE 11

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

b-ONE™ Primary Acetabular System - 00843575100139 Catalog Number : 881906144C

Device Description : SHELL TRIAL, 44MM OUTER DIAMETER, LINER SIZE C

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

b-ONE™ Primary Acetabular System - 00843575100146 Catalog Number : 881906146D

Device Description : SHELL TRIAL, 46MM OUTER DIAMETER, LINER SIZE D

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

b-ONE™ Primary Acetabular System - 00843575100153 Catalog Number : 881906148E

Device Description : SHELL TRIAL, 48MM OUTER DIAMETER, LINER SIZE E

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

b-ONE™ Primary Acetabular System - 00843575100160 Catalog Number : 881906150F

Device Description : SHELL TRIAL, 50MM OUTER DIAMETER, LINER SIZE F

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

b-ONE™ Primary Acetabular System - 00843575100177 Catalog Number : 881906152G

Device Description : SHELL TRIAL, 52MM OUTER DIAMETER, LINER SIZE G

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

b-ONE™ Primary Acetabular System - 00843575100184 Catalog Number : 881906154H

Device Description : SHELL TRIAL, 54MM OUTER DIAMETER, LINER SIZE H

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : HWC, MEH, LZO

Prescription Use : Yes

Device Count : 1

b-ONE™ Primary Acetabular System - 00843575100191 Catalog Number : 881906156I

Device Description : SHELL TRIAL,56MM OUTER DIAMETER, LINER SIZE I

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

b-ONE™ Primary Acetabular System - 00843575100207 Catalog Number : 881906158J

Device Description : SHELL TRIAL, 58MM OUTER DIAMETER, LINER SIZE J

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : MEH, HWC, LZO

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 5 … 98 Next