FDA.reportPublic FDA data

Orthopaedic implant/instrument assembling device

Definition
A non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.
GUDID devices
682
Last updated
2026-10-04 01:38:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10888857001121DENALI MI Spinal SystemVB Spine LLC1001-901332022-08-09
10888857010444DENALI Spinal SystemVB Spine LLC101-901902022-07-25
10888857011267DENALI Spinal SystemVB Spine LLC101-903172022-07-25
10888857025615CHESAPEAKE Stabilization SystemVB Spine LLC2008-900432022-06-06
10888857039889EVEREST Spinal SystemVB Spine LLC2901-900182022-08-06
10888857082397CHESAPEAKE Stabilization SystemVB Spine LLC3608-900082022-06-01
10888857111493ALEUTIAN® Interbody SystemsVB Spine LLC5303-901092021-04-07
10888857157767ALEUTIAN® Interbody SystemsVB Spine LLC5203-900102021-04-07
10888857554269CASCADIA Interbody SystemVB Spine LLC8030-902072024-01-04
10886982000958NASynthes GmbHE5115-5/12017-02-20
10886982000965NASynthes GmbHE5115-5/102017-02-20
10886982000972NASynthes GmbHE5115-5/122017-02-20
10886982000989NASynthes GmbHE5115-5/142017-02-20
10886982000996NASynthes GmbHE5115-5/32017-02-20
10886982001009NASynthes GmbHE5115-5/42017-02-20
10886982001016NASynthes GmbHE5115-5/62017-02-20
10886982001023NASynthes GmbHE5115-5/82017-02-20
00889024699762ROSA® ShoulderOrthosoft Inc20-8087-142-002026-06-26
00889024699779ROSA® ShoulderOrthosoft Inc20-8087-141-002026-06-26
10806378067341ACUMEDAcumed LLCFX-4000-S2015-10-24
00190376146522InvictusALPHATEC SPINE, INC.161332020-06-17
00190376146553InvictusALPHATEC SPINE, INC.161512020-06-17
00190376148168InvictusALPHATEC SPINE, INC.161112020-06-17
00190376148663InvictusALPHATEC SPINE, INC.161422020-06-17
00190376172491IdentiTiALPHATEC SPINE, INC.127-4002020-06-17
00190376192284LIF AccessALPHATEC SPINE, INC.274042020-06-17
00190376192864InvictusALPHATEC SPINE, INC.171512020-06-17
00190376195926InvictusALPHATEC SPINE, INC.171422020-06-17
00190376206318InvictusALPHATEC SPINE, INC.171692020-06-17
00190376666259AscendALPHATEC SPINE, INC.160-6002025-10-21
00190376688763IdentiTi IIALPHATEC SPINE, INC.837-4002025-10-15
00190376694252IdentiTi IIALPHATEC SPINE, INC.823-4012025-11-19
00192629235663DynastyMicroport Orthopedics Inc.DMAPRESS2021-10-07
00192629260719DynastyMicroport Orthopedics Inc.DMBPRESS2021-10-07
00192629271494EVOLUTION®Microport Orthopedics Inc.E1100357CN2020-05-28
00192629271678EVOLUTION®Microport Orthopedics Inc.E2102001CN2020-05-28
00192629271685EVOLUTION®Microport Orthopedics Inc.E2100210CN2020-05-28
00192629271692EVOLUTION®Microport Orthopedics Inc.E2102013CN2020-05-28
00192629271708EVOLUTION®Microport Orthopedics Inc.E2102002CN2020-05-28
00192629271715EVOLUTION®Microport Orthopedics Inc.E2102006CN2020-05-28
00811801030895General InstrumentsALPHATEC SPINE, INC.CI-104832020-09-19
00840124522169Metalogix RevolutionFUSION ORTHOPEDICS, LLCCD-MX-99502025-10-16
00840124522176Metalogix RevolutionFUSION ORTHOPEDICS, LLCCD-MX-99512025-10-16
00840180541517General InstrumentsALPHATEC SPINE, INC.CI-11875-12025-10-17
00840180545843General InstrumentsALPHATEC SPINE, INC.CI-11983-1002026-05-15
00840326408636OrthoquestYoung Innovations, Inc.G1432022-11-03
00840326408643OrthoquestYoung Innovations, Inc.G143F2022-11-03
00840326408650OrthoquestYoung Innovations, Inc.G143H2022-11-03
00840326408667OrthoquestYoung Innovations, Inc.G143S2022-11-03
00840967133638ZodiacALPHATEC SPINE, INC.929692020-06-17
00840967190259BridgePointALPHATEC SPINE, INC.249092020-06-17
00840967192727IllicoALPHATEC SPINE, INC.73561-R2020-06-17
00840967192901IllicoALPHATEC SPINE, INC.737722020-06-17
00840967192970IllicoALPHATEC SPINE, INC.737792020-06-17
00840967192994IllicoALPHATEC SPINE, INC.737952020-06-17
00840967195094ZodiacALPHATEC SPINE, INC.929622020-06-17
00843575120076MOBIO™ Sizer BalancerB-ONE ORTHO, CORP.8829P030012023-01-13
00844856006003BattalionALPHATEC SPINE, INC.278072020-06-17
00844856006058BattalionALPHATEC SPINE, INC.278082020-06-17
00844856027381NovelALPHATEC SPINE, INC.640962020-06-17
00844856028043NovelALPHATEC SPINE, INC.646392020-06-17
00844856041691IllicoALPHATEC SPINE, INC.737242020-06-17
00844856042056IllicoALPHATEC SPINE, INC.737542020-06-17
00844856042650IllicoALPHATEC SPINE, INC.737552020-06-17
00844856043886NovelALPHATEC SPINE, INC.648202020-06-17
00844856043893NovelALPHATEC SPINE, INC.649062020-06-17
00844856044098IllicoALPHATEC SPINE, INC.737262020-06-17
00847538018592GLOBAL UNITE™ Short Stem InstrumentationSYMMETRY MEDICAL INC.2307843002021-09-01
00889797106122Made-To-OrderWRIGHT MEDICAL TECHNOLOGY, INC.SMS003482022-12-08
00889797106153Made-To-OrderWRIGHT MEDICAL TECHNOLOGY, INC.SMS003492022-12-08
03662200012985NOVAESOC ETUDES RECHERCHES FABRICATIONET2022-12-09
03662200013197NOVAESOC ETUDES RECHERCHES FABRICATIONMI 6032022-12-09
03662200013210NOVAESOC ETUDES RECHERCHES FABRICATIONMP0102022-12-09
03662200013234NOVAESOC ETUDES RECHERCHES FABRICATIONTIV0092022-12-09
03662200013401NOVAESOC ETUDES RECHERCHES FABRICATIONPPN E2022-12-09
03662200013425NOVAESOC ETUDES RECHERCHES FABRICATIONTFT-AO2022-12-09
03662200016266NOVAESOC ETUDES RECHERCHES FABRICATIONCOJB 122022-12-09
03662200016297NOVAESOC ETUDES RECHERCHES FABRICATIONBAJB 22022-12-09
04026575080236LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KG134-100/412022-12-20
04026575081004LINK Instruments - Trial implants and size gaugesWALDEMAR LINK GmbH & Co. KG134-100/612022-12-20