FDA.reportPublic FDA data

Orthopaedic prosthesis implantation instrument, reusable

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 reusable device intended to be sterilized prior to use.
GUDID devices
29,729
Last updated
2023-05-01 08:45:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840338602701Tornier HRSTORNIER, INC.ARS7422012023-04-21
00840338602718Tornier HRSTORNIER, INC.ARS7422022023-04-21
00840338602725Tornier HRSTORNIER, INC.ARS7422032023-04-21
00840338602732Tornier HRSTORNIER, INC.ARS7422042023-04-21
00840338602749Tornier HRSTORNIER, INC.ARS7422052023-04-21
00840338602756Tornier HRSTORNIER, INC.ARS7422062023-04-21
10888857347793EVEREST Spinal SystemVB Spine LLCSP-23522023-04-21
10888857455269EVEREST Spinal SystemVB Spine LLCSP-40232023-04-21
10888857560703ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-012023-04-21
10888857560710ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-022023-04-21
10888857560727ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-032023-04-21
10888857560734ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-042023-04-21
10888857560741ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-052023-04-21
10888857560758ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-062023-04-21
10888857560765ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-072023-04-21
10888857560772ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-082023-04-21
10888857560789ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-092023-04-21
10888857560796ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-102023-04-21
10888857560802ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-112023-04-21
10888857560819ALEUTIAN Interbody SystemsVB Spine LLCPRO-1306-122023-04-21
09421028118330Patella Drill Guide - Novosource 29-38mmENZTEC LIMITED4240-65702023-04-20
09421028118538Enztec Premium Patella Cement Clamp – Full ContactENZTEC LIMITED4240-44202023-04-20
00190446764991DJO SURGICALEncore Medical, L.P.803-61-0302023-04-14
00190446188919DJO SURGICALEncore Medical, L.P.801-05-0322023-04-10
00190446188933DJO SURGICALEncore Medical, L.P.801-05-0332023-04-10
00190446188940DJO SURGICALEncore Medical, L.P.801-05-0342023-04-10
00190446188957DJO SURGICALEncore Medical, L.P.801-05-0352023-04-10
00190446255741DJO SURGICALEncore Medical, L.P.800-05-0822023-04-10
00190446255758DJO SURGICALEncore Medical, L.P.800-05-0832023-04-10
00190446255765DJO SURGICALEncore Medical, L.P.800-05-0842023-04-10
00190446255772DJO SURGICALEncore Medical, L.P.800-05-0852023-04-10
00190446255789DJO SURGICALEncore Medical, L.P.800-05-0862023-04-10
00190446255796DJO SURGICALEncore Medical, L.P.800-05-0872023-04-10
00190446255802DJO SURGICALEncore Medical, L.P.800-05-0882023-04-10
00190446255819DJO SURGICALEncore Medical, L.P.800-05-0892023-04-10
00190446255826DJO SURGICALEncore Medical, L.P.800-05-0902023-04-10
00190446255833DJO SURGICALEncore Medical, L.P.800-05-0912023-04-10
00888912122863DJO SURGICALDJO, LLC800-01-1772023-04-10
00888912122870DJO SURGICALDJO, LLC800-01-1782023-04-10
00888912122887DJO SURGICALDJO, LLC800-01-1792023-04-10
00888912122894DJO SURGICALDJO, LLC800-01-1802023-04-10
00888912122900DJO SURGICALDJO, LLC800-01-1812023-04-10
00888912122917DJO SURGICALDJO, LLC800-01-1822023-04-10
00888912123693DJO SURGICALEncore Medical, L.P.800-01-2872023-04-10
00888912123822DJO SURGICALEncore Medical, L.P.800-01-3112023-04-10
00888912124249DJO SURGICALEncore Medical, L.P.800-01-3572023-04-10
00888912124270DJO SURGICALEncore Medical, L.P.800-01-3602023-04-10
00888912124287DJO SURGICALEncore Medical, L.P.800-01-3612023-04-10
00888912124294DJO SURGICALEncore Medical, L.P.800-01-3622023-04-10
00888912124300DJO SURGICALEncore Medical, L.P.800-01-3632023-04-10
00888912124324DJO SURGICALEncore Medical, L.P.800-01-3652023-04-10
00888912124331DJO SURGICALEncore Medical, L.P.800-01-3662023-04-10
00888912124348DJO SURGICALEncore Medical, L.P.800-01-3672023-04-10
00888912124355DJO SURGICALEncore Medical, L.P.800-01-3682023-04-10
00888912124362DJO SURGICALEncore Medical, L.P.800-01-3692023-04-10
00888912124379DJO SURGICALEncore Medical, L.P.800-01-3702023-04-10
00888912124393DJO SURGICALEncore Medical, L.P.800-01-3722023-04-10
00888912124409DJO SURGICALEncore Medical, L.P.800-01-3732023-04-10
00888912124416DJO SURGICALEncore Medical, L.P.800-01-3742023-04-10
00888912124423DJO SURGICALEncore Medical, L.P.800-01-3752023-04-10
00888912124430DJO SURGICALEncore Medical, L.P.800-01-3762023-04-10
00888912124447DJO SURGICALEncore Medical, L.P.800-01-3772023-04-10
00888912124461DJO SURGICALEncore Medical, L.P.800-01-3792023-04-10
00888912124478DJO SURGICALEncore Medical, L.P.800-01-3802023-04-10
00888912124485DJO SURGICALEncore Medical, L.P.800-01-3812023-04-10
00888912124515DJO SURGICALEncore Medical, L.P.800-01-3872023-04-10
00888912124522DJO SURGICALEncore Medical, L.P.800-01-3882023-04-10
00888912124539DJO SURGICALEncore Medical, L.P.800-01-3892023-04-10
00888912124546DJO SURGICALEncore Medical, L.P.800-01-3902023-04-10
00888912124553DJO SURGICALEncore Medical, L.P.800-01-3912023-04-10
00888912124560DJO SURGICALEncore Medical, L.P.800-01-3922023-04-10
00888912124836DJO SURGICALEncore Medical, L.P.800-01-4192023-04-10
00888912124843DJO SURGICALEncore Medical, L.P.800-01-4202023-04-10
00888912124850DJO SURGICALEncore Medical, L.P.800-01-4212023-04-10
00888912124867DJO SURGICALEncore Medical, L.P.800-01-4222023-04-10
00888912124874DJO SURGICALEncore Medical, L.P.800-01-4232023-04-10
00888912124881DJO SURGICALEncore Medical, L.P.800-01-4242023-04-10
00888912125239DJO SURGICALEncore Medical, L.P.800-02-2882023-04-10
00888912125246DJO SURGICALEncore Medical, L.P.800-02-2892023-04-10
00888912125253DJO SURGICALEncore Medical, L.P.800-02-2902023-04-10