B One Ortho Corp

FDA Filings

This page includes the latest FDA filings for B One Ortho Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3016093326
FEI Number3016093326
NameB-ONE ORTHO, CORP.
Owner & Operatorb-ONE Ortho, Corp.
Contact Address3 Wing Drive Suite #259
Cedar Knolls NJ 07927 US
Official Correspondent
  • Imants Liepins
  • x-973-5878431-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address636 Shelby Street Floor 4
Bristol, TN 37620 US

Registration Number3015259876
FEI Number3015259876
NameB-ONE ORTHO, CORP.
Owner & Operatorb-ONE Ortho, Corp.
Contact Address3 Wing Drive Suite #259
Cedar Knolls NJ 07927 US
Official Correspondent
  • Imants Liepins
  • x-973-5878431-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3 Wing Drive Suite #259
Cedar Knolls, NJ 07927 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050102026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050092026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050082026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050072026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050062026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050052026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050042026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050032026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P050022026-02-23
B-ONE ORTHO, CORP.
 Mobio™ Specialty 8829P030902026-02-23
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321721L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321701L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321681L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321661L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321641L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321621L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321621K2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321601K2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321601J2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321581J2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321581I2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321561I2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321561H2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321541H2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321541G2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321521G2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321521F2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321501F2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321501E2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321481E2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321481D2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321461D2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321461C2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881321441C2026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132112026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132102026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132092026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132082026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132072026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132062026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132052026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132042026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132032026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132022026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100132012026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127112026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127102026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127092026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127082026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127072026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127062026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127052026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127042026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127032026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127022026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88100127012026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88199103012026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88199101012026-02-19
B-ONE ORTHO, CORP.
 PRIMO™ Acetabular Cup System 88199102032026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88199102022026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88199102012026-02-19
B-ONE ORTHO, CORP.
 b-ONE Hip Instrumentation 88199100042026-02-19
B-ONE ORTHO, CORP.
 b-ONE Hip Instrumentation 88199100032026-02-19
B-ONE ORTHO, CORP.
 PRIMO™ Acetabular Cup System 88199102002026-02-19
B-ONE ORTHO, CORP.
 b-ONE Hip Instrumentation 88199100012026-02-19
B-ONE ORTHO, CORP.
 Juveno™ Femoral Hip System 88199101002026-02-19
B-ONE ORTHO, CORP.
 b-ONE Hip Instrumentation 88199100002026-02-19
B-ONE ORTHO, CORP.
 b-ONE Hip Instrumentation 88199100102026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88190460732026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88190460722026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88190460712026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88190460702026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88190460692026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88190460682026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88190460672026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 88190460662026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881906172L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881906170L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881906168L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881906166L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881312721L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881312701L2026-02-19
B-ONE ORTHO, CORP.
 Primo™ Acetabular System 881312681L2026-02-19
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400142025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400132025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400122025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400112025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400102025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400092025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400082025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400072025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400062025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400052025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400042025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400032025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400022025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190400012025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190000262025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190000252025-04-15
B-ONE ORTHO, CORP.
 Kosmo Femoral Hip System 88190000242025-04-15
B-ONE ORTHO, Corp.
B-ONER MOBIO Total Knee System2022-10-06
B-ONE ORTHO, Corp.
B-ONE MOBIO Total Knee System2022-01-21
B-ONE ORTHO, Corp
OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System2021-11-04
B-ONE ORTHO, Corp.
MOBIO Total Knee System2021-04-21
B-One Ortho Corp.
KOSMO Femoral Stem2021-04-01
B-One Ortho, Corp.
Mobio Total Knee System2020-10-23
B-ONE Ortho Corp.
Juveno Hip System Femoral Stem, B-ONE Primary Acetabular System Cups2019-02-14
B-One Ortho Corp.
MOBIO Total Knee System Posterior Stabilized (PS And PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component2019-01-28
B-One Ortho Corp.
B-ONE Total Knee System2018-10-12
B-One Ortho Corp.
B-ONE® Total Hip System2018-08-30

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