FDA.reportPublic FDA data

Orthopaedic prosthesis implantation instrument, single-use

Definition
A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a single-use device.
GUDID devices
1,905
Last updated
2023-02-24 09:28:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07630030891533MyKneeMedacta International SA6.22232023-02-16
04046955183012AESCULAPAesculap AGSZ072SU2022-11-25
04046955183029AESCULAPAesculap AGSZ073SU2022-11-25
04046955183036AESCULAPAesculap AGSZ074SU2022-11-25
04046955186372ENNOVATE CAesculap AGSZ119SU2022-11-25
04046955186389ENNOVATE CAesculap AGSZ120SU2022-11-25
04046955186396ENNOVATE CAesculap AGSZ121SU2022-11-25
04046955289714ENNOVATE CAesculap AGSZ123SU2022-11-25
04046955624751ENNOVATE CAesculap AGSZ013R2022-11-25
04046955624768ENNOVATE CAesculap AGSZ014R2022-11-25
04046955624775ENNOVATE CAesculap AGSZ015R2022-11-25
04046955624782ENNOVATE CAesculap AGSZ016R2022-11-25
04046955624799ENNOVATE CAesculap AGSZ017R2022-11-25
04046955624805ENNOVATE CAesculap AGSZ018R2022-11-25
04046955624812ENNOVATE CAesculap AGSZ019R2022-11-25
04046955624829ENNOVATE CAesculap AGSZ020R2022-11-25
04046955624836ENNOVATE CAesculap AGSZ102R2022-11-25
04046955624843ENNOVATE CAesculap AGSZ103R2022-11-25
04046955624850ENNOVATE CAesculap AGSZ136R2022-11-25
04046955624867ENNOVATE CAesculap AGSZ137R2022-11-25
00887868519017iASSIST® Knee SystemOrthosoft Inc20-8011-501-002022-11-15
00887868552151ROSA® KneeOrthosoft Inc20-8020-194-002022-10-20
00887868552168ROSA® KneeOrthosoft Inc20-8020-195-002022-10-20
00887868552175ROSA® KneeOrthosoft Inc20-8020-196-002022-10-20
00887868540509iASSIST Knee v2 PodOrthosoft Inc20-8011-501-002022-10-17
00889797100038PROstep TBCWRIGHT MEDICAL TECHNOLOGY, INC.977000172022-08-10
00810082897845Lapiprep Lapidus Preparation SystemMedartis Inc.LPSAWBLDS2022-08-03
00810082897852Lapiprep Lapidus Preparation SystemMedartis Inc.LPKWIRES2022-08-03
00887868522987Signature ONEOrthosoft Inc20-8090-008-012022-07-20
00887868522994Signature ONEOrthosoft Inc20-8090-008-022022-07-20
07630030868061MyKneeMedacta International SA4.2025SM2022-06-08
07630345752864MySpine Medacta International SA7.07302022-05-30
07630345752871MySpine Medacta International SA7.0730S2022-05-30
07630345752888MySpine Medacta International SA7.07312022-05-30
07630345752895MySpine Medacta International SA7.0731S2022-05-30
07630345752901MySpine Medacta International SA7.07322022-05-30
07630345752918MySpine Medacta International SA7.0732S2022-05-30
03613720221876IMPIX-MANTAMEDICREA INTERNATIONALA201517632017-01-31
03613720221883IMPIX-MANTAMEDICREA INTERNATIONALA201517732017-01-31
03613720221982IMPIX-MANTAMEDICREA INTERNATIONALA201522532017-01-31
03613720221999IMPIX-MANTAMEDICREA INTERNATIONALA201522632017-01-31
03613720222002IMPIX-MANTAMEDICREA INTERNATIONALA201522732017-01-31
03613720236016IMPIX-MANTAMEDICREA INTERNATIONALA201504072017-01-31
03613720236023IMPIX-MANTAMEDICREA INTERNATIONALA201505672017-01-31
03613720236030IMPIX-MANTAMEDICREA INTERNATIONALA201519532017-01-31
03613720236047IMPIX-MANTAMEDICREA INTERNATIONALA201519632017-01-31
03613720236054IMPIX-MANTAMEDICREA INTERNATIONALA201519732017-01-31
03613720236078IMPIX-MANTAMEDICREA INTERNATIONALA202504072017-01-31
03613720236085IMPIX-MANTAMEDICREA INTERNATIONALA202505672017-01-31
03613720236092IMPIX-MANTAMEDICREA INTERNATIONALA203504072017-01-31
03613720236108IMPIX-MANTAMEDICREA INTERNATIONALA203505672017-01-31
07630971283190MyKnee R Pin PositionersMedacta International SA17.10112022-05-06
07630971283206MyKnee R Pin PositionersMedacta International SA17.1011S2022-05-06
07630971283213MyKnee R Pin PositionersMedacta International SA17.10122022-05-06
07630971283220MyKnee R Pin PositionersMedacta International SA17.1012S2022-05-06
07630971283237MyKnee R Pin PositionersMedacta International SA17.10132022-05-06
07630971283244MyKnee R Pin PositionersMedacta International SA17.1013S2022-05-06
07630971283251MyKnee R Pin PositionersMedacta International SA17.10142022-05-06
07630971283268MyKnee R Pin PositionersMedacta International SA17.1014S2022-05-06
07630971283275MyKnee R Pin PositionersMedacta International SA17.10152022-05-06
07630971283282MyKnee R Pin PositionersMedacta International SA17.1015S2022-05-06
07630971283299MyKnee R Pin PositionersMedacta International SA17.10162022-05-06
07630971283305MyKnee R Pin PositionersMedacta International SA17.1016S2022-05-06
07630971283312MyKnee R Pin PositionersMedacta International SA17.10212022-05-06
07630971283329MyKnee R Pin PositionersMedacta International SA17.1021S2022-05-06
07630971283336MyKnee R Pin PositionersMedacta International SA17.10222022-05-06
07630971283343MyKnee R Pin PositionersMedacta International SA17.1022S2022-05-06
07630971283350MyKnee R Pin PositionersMedacta International SA17.10232022-05-06
07630971283367MyKnee R Pin PositionersMedacta International SA17.1023S2022-05-06
07630971283374MyKnee R Pin PositionersMedacta International SA17.10242022-05-06
07630971283381MyKnee R Pin PositionersMedacta International SA17.1024S2022-05-06
07630971283398MyKnee R Pin PositionersMedacta International SA17.10252022-05-06
07630971283404MyKnee R Pin PositionersMedacta International SA17.1025S2022-05-06
07630971283411MyKnee R Pin PositionersMedacta International SA17.10262022-05-06
07630971283428MyKnee R Pin PositionersMedacta International SA17.1026S2022-05-06
07630971283435MyKnee R Pin PositionersMedacta International SA17.10312022-05-06
07630971283442MyKnee R Pin PositionersMedacta International SA17.1031S2022-05-06
07630971283459MyKnee R Pin PositionersMedacta International SA17.10322022-05-06
07630971283466MyKnee R Pin PositionersMedacta International SA17.1032S2022-05-06
07630971283473MyKnee R Pin PositionersMedacta International SA17.10332022-05-06