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b-ONE Ortho Corp.

US

Last updated September 17, 2026

Information

Country
US
Address
159 Dwight Pl, Fairfield, NJ, 07004
Website
—
LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3042508254
DUNS Number
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Catalogue (1198)

Page 24 of 24
DeviceModel / ReferenceRegistriesClassStatus
MOBIO™ Total Knee System 8821321513
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8821323716
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8821321713
FDA UDI
Class IIActive
b-ONE Hip Instrumentation 8819106014
FDA UDI
Class IActive
MOBIO™ Total Knee System 8821313019
FDA UDI
Class IIActive
b-ONE Hip Instrumentation 8819900501
FDA UDI
Class IActive
MOBIO™ Total Knee System 8829105321
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8821333022
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8829106009
FDA UDI
Class IIActive
b-ONE™ Primary Acetabular System 881201321H
FDA UDI
Class IIActive
b-ONE™ Primary Acetabular System 881200281F
FDA UDI
Class IIActive
Kosmo Femoral Hip System 8810402255
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8829303011
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8829111051
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8829006350
FDA UDI
Class IActive
b-ONE™ 12/14 Taper Femoral Head 8819053362
FDA UDI
Class IActive
Kosmo Femoral Hip System 8819040014
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8829214047
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8821333119
FDA UDI
Class IIActive
b-ONE™ Primary Acetabular System 881906436G
FDA UDI
Class IActive
MOBIO™ Total Knee System 8829312019
FDA UDI
Class IIActive
b-ONE™ Primary Acetabular System 8814006550
FDA UDI
Class IIActive
Kosmo Femoral Hip System 8819040008
FDA UDI
Class IActive
MOBIO™ Total Knee System 8829305112
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8821343011
FDA UDI
Class IIActive
Juveno™ Femoral Hip System 8810003202
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8821122041
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8829111071
FDA UDI
Class IIActive
b-ONE™ Primary Acetabular System 881200321H
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8829304210
FDA UDI
Class IIActive
Kosmo Femoral Hip System 8810101060
FDA UDI
Class IIActive
MOBIO™ Total Knee System 8829101120
FDA UDI
Class IActive
b-ONE™ 12/14 Taper Femoral Head 8819053283
FDA UDI
Class IActive
MOBIO™ Total Knee System 8829306016
FDA UDI
Class IIActive
b-ONE™ Primary Acetabular System 8819023000
FDA UDI
Class IActive
b-ONE™ Primary Acetabular System 881200281C
FDA UDI
Class IIActive
b-ONE® Total Hip System K240528
FDA 510(k)
Class IIActive
KOSMO Femoral Stem K202768
FDA 510(k)
Class IIActive
MOBIO Total Knee System K210483
FDA 510(k)
Class IIActive
b-ONER MOBIO Total Knee System K222431
FDA 510(k)
Class IIActive
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System K212912
FDA 510(k)
Class IIActive
b-ONE® Total Hip System K173380
FDA 510(k)
Class IIActive
Mobio Total Knee System K202429
FDA 510(k)
Class IIActive
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component K183025
FDA 510(k)
Class IIActive
b-ONE MOBIO Total Knee System K213673
FDA 510(k)
Class IIActive
b-ONE® Bipolar Head K253357
FDA 510(k)
Class IIActive
b-ONE Total Knee System K180446
FDA 510(k)
Class IIActive
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups K182705
FDA 510(k)
Class IIActive

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