Orthosoft Inc

FDA Filings

This page includes the latest FDA filings for Orthosoft Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
Orthosoft Inc
ROSA® Shoulder 208087506002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087134002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087133002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087132002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087131002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087130002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087129002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087128002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087127002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087126002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087700002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087503002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087501002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087504002024-03-14
Orthosoft Inc
ROSA® Shoulder ROSAR230212024-03-14
Orthosoft Inc
ROSA® Shoulder 208087900002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087604002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087603002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087602002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087601002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087600002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087402002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087401002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087400002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087302002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087301002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087300002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087201002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087200002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087125002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087123002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087102002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087101002024-03-14
Orthosoft Inc
ROSA® Shoulder 208087100032024-03-14
Orthosoft Inc
ROSA® Shoulder 208087100022024-03-14
Orthosoft Inc
ROSA® Shoulder 208087100012024-03-14
Orthosoft Inc
Signature™ Comprehensive® 20-8090-009-022024-02-19
Orthosoft Inc
Signature™ Comprehensive® 20-8090-009-012024-02-19
Orthosoft Inc
OptiVu™ Mixed Reality OVMR-SW-2-02022023-09-15
Orthosoft Inc
OptiVu™ Mixed Reality OVMR-SW-2-02012023-09-15
Orthosoft Inc
ROSA® 20-8020-160-002023-04-18
Orthosoft Inc
ROSA® 20-8020-159-002023-04-18
Orthosoft Inc
ROSA® 20-8020-158-002023-04-18
Orthosoft Inc
OptiVu™ Mixed Reality OVMR-SW-2-00062023-04-10
Orthosoft Inc
OptiVu™ Mixed Reality OVMR-SW-2-00052023-04-10
Orthosoft Inc
iASSIST® Knee System 20-8011-501-002022-11-23
Orthosoft Inc
iASSIST® Knee System 20-8011-065-002022-11-22
Orthosoft Inc
iASSIST® Knee System 20-8011-063-002022-11-22
Orthosoft Inc
iASSIST® Knee System 20-8000-070-032022-11-22
Orthosoft Inc
iASSIST® Knee System 20-8000-070-022022-11-22
Orthosoft Inc
ROSA® Knee 20-8020-193-002022-10-28
Orthosoft Inc
ROSA® Knee 20-8020-192-002022-10-28
Orthosoft Inc
ROSA® Knee 20-8020-191-002022-10-28
Orthosoft Inc
ROSA® Knee 20-8020-190-002022-10-28
Orthosoft Inc
ROSA® Knee 20-8020-196-002022-10-28
Orthosoft Inc
ROSA® Knee 20-8020-195-002022-10-28
Orthosoft Inc
ROSA® Knee 20-8020-194-002022-10-28
Orthosoft Inc
iASSIST Knee v2 Pod 2022-10-25
Orthosoft Inc
iASSIST® Knee System 20-8011-900-132022-09-29
Orthosoft Inc
iASSIST® Knee System 302.40212022-09-29
Orthosoft Inc
PSI Knee 803.3022022-08-19
Orthosoft Inc
X-PSI Knee 803.3082022-08-19
Orthosoft, Inc. (d/b/a Zimmer CAS)
OptiVu ROSA MxR2022-07-29
Orthosoft Inc
Signature ONE 2022-07-28
Orthosoft Inc
Signature ONE 2022-07-28
Orthosoft Inc
ROSA® 2022-07-25
Orthosoft Inc
ROSA® 2022-07-25
Orthosoft Inc
ROSA® 2022-07-25
Orthosoft Inc
ROSA® 2022-07-25
Orthosoft Inc
ROSA® 2022-07-25
Orthosoft Inc
Signature ONE Software Package 302.40182022-07-13
Orthosoft Inc
Signature ONE Software Package 302.40182022-07-13
Orthosoft Inc
Signature ONE Software Package 302.40182022-07-13
Orthosoft, Inc (d/b/a Zimmer CAS)
ROSA® Knee System2022-04-22
Orthosoft Inc. (d/b/a Zimmer CAS)
Signature™ ONE System2021-10-12
Orthosoft Inc
Tablet Power Cord 20-8060-400-032021-09-07
Orthosoft Inc
Tablet Battery Bay 20-8060-403-002021-09-07
Orthosoft Inc
Tablet Battery 20-8060-402-002021-09-07
Orthosoft Inc
ROSA Hip Impaction Instrument Case 20-8060-306-002021-09-01
Orthosoft Inc
ROSA Hip Software 20-8060-400-012021-09-01
Orthosoft Inc
ROSA Tablet 20-8060-400-002021-09-01
Orthosoft Inc
ROSA Cup Inserter Screw 20-8060-305-002021-09-01
Orthosoft Inc
ROSA Cup Inserter Adaptor 20-8060-304-002021-09-01
Orthosoft Inc
ROSA Offset Cup Inserter Shaft 20-8060-303-002021-09-01
Orthosoft Inc
ROSA Straight Cup Inserter Shaft 20-8060-302-002021-09-01
Orthosoft Inc
ROSA Cup Inserter Handle 20-8060-301-002021-09-01
Orthosoft Inc
ROSA Quick Connect Sleeve 20-8060-002-002021-09-01
Orthosoft Inc
ROSA Quick Connect Interface 20-8060-001-002021-09-01
Orthosoft Inc
ONE Planner Hip CG2002021-08-05
Orthosoft Inc
ROSA Partial Knee Software V1.0 2021-05-07
Orthosoft Inc
iASSIST ® 2021-02-26
Orthosoft Inc
Sesamoid ® 20-8000-000-112021-02-17
Orthosoft Inc
Sesamoid ® 20-8000-000-102021-02-17
Orthosoft Inc
Sesamoid ® 20-8000-000-112021-02-05
Orthosoft Inc
Sesamoid ® 20-8000-000-102021-02-05
Orthosoft Inc. (d/b/a Zimmer CAS)
Signature ONE System2020-06-05
Orthosoft Inc
iASSIST® 20-8011-070-192020-01-22
Orthosoft Inc
iASSIST® 20-8011-070-242020-01-22
Orthosoft Inc
iASSIST® 20-8011-070-012020-01-15
Orthosoft Inc. (d/b/a Zimmer CAS)
IASSIST Knee System2019-11-05
Orthosoft Inc
ROSA® 20-8020-029-00 2019-10-25
Orthosoft Inc
ROSA® 20-8020-028-00 2019-10-25
Orthosoft Inc
Efficient Care 3D Planning 302.40142019-10-25
Orthosoft Inc
TMR+™ Shoulder Guide and Bone Model Right 20-8090-001-022019-09-03
Orthosoft Inc
TMR+™ Shoulder Guide and Bone Model Left 20-8090-001-012019-09-03
Orthosoft, Inc. (d/b/a Zimmer CAS)
Signature ONE System2019-08-30
Orthosoft, Inc. (d/b/a Zimmer CAS)
Efficient Care 3D Planning2019-08-23
Orthosoft Inc. (d/b/a Zimmer CAS)
Signature ONE System2019-06-05
Orthosoft Inc. (d/b/a Zimmer CAS)
ROSA Knee System2019-01-24
Orthosoft Inc. (d/b/a Zimmer CAS)
X-PSI Knee System2017-12-28
ORTHOSOFT, INC.
CAS PSI KNEE SYSTEM2013-09-13
ORTHOSOFT, INC.
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM2010-04-05
ORTHOSOFT, INC.
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL2007-09-19
ORTHOSOFT, INC.
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-060032007-07-20
ORTHOSOFT, INC.
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-050022006-04-28
ORTHOSOFT, INC.
NAVITRACK SYSTEM - S&N IMAGE FREE KNEE2005-01-14
ORTHOSOFT, INC.
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-030172004-06-22
ORTHOSOFT, INC.
NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE2003-10-21
ORTHOSOFT, INC.
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.2042003-05-23
ORTHOSOFT, INC.
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.0052003-05-09
ORTHOSOFT, INC.
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.2002003-02-04
ORTHOSOFT, INC.
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.1202002-08-27
ORTHOSOFT, INC.
NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.0042000-08-03
ORTHOSOFT, INC.
NAVITRACK1998-07-09

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