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) (8) Orthopedic Manual Surgical Instrument (LXH) (1) Template (HWT) (1)

Premarket Exempt

No Yes

Clear

AR Specialty Femoral - 00843575112484 Catalog Number : 8829P00033

Device Description : AR Cut block - w/ flange - Open - size 3

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112491 Catalog Number : 8829P00034

Device Description : AR Cut block - w/ flange - Open - size 4

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112507 Catalog Number : 8829P00035

Device Description : AR Cut block - w/ flange - Open - size 5

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112514 Catalog Number : 8829P00036

Device Description : AR Cut block - w/ flange - Open - size 6

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112521 Catalog Number : 8829P00037

Device Description : AR Cut block - w/ flange - Open - size 7

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112538 Catalog Number : 8829P00038

Device Description : AR Cut block - w/ flange - Open - size 8

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112545 Catalog Number : 8829P00039

Device Description : AR Cut block - w/ flange - Open - size 9

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112552 Catalog Number : 8829P00004

Device Description : Femoral AR Sizer

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112569 Catalog Number : 8829P00008

Device Description : Headed Pin, Thick

Device Class : 1

Duns Number: 081315444

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

AR Specialty Femoral - 00843575112576 Catalog Number : 8829P00009

Device Description : AR Skim Cut

Device Class : 2

Duns Number: 081315444

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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