FDA.reportPublic FDA data

Orthopaedic implant impactor, reusable

Definition
A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.
GUDID devices
847
Last updated
2026-02-05 16:16:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06438394000247Activa InstrumentBioretec OyB-IP-27002026-01-28
54026704797993PILLINGTELEFLEX INCORPORATEDIPN0197302022-12-08
54026704798921PILLINGTELEFLEX INCORPORATEDIPN0200302022-12-08
54026704798938PILLINGTELEFLEX INCORPORATEDIPN9124212022-12-08
54026704798945PILLINGTELEFLEX INCORPORATEDIPN0200332022-12-08
54026704798952PILLINGTELEFLEX INCORPORATEDIPN0200372022-12-08
08806373888878BENCOX Surgical InstrumentsCorentec Co., Ltd01.55.0262026-01-16
03662663220903Breckenridge ACDF SystemHighridge Medical, LLC8030-16012026-01-13
03662663220910Breckenridge ACDF SystemHighridge Medical, LLC8030-17012026-01-13
03662663220927Breckenridge ACDF SystemHighridge Medical, LLC8030-18012026-01-13
09421028111300Enztec Classic OCI - CorinENZTEC LIMITED39910552026-01-06
09421028111317Enztec Classic OCI - Corin TrinketENZTEC LIMITED39910550012026-01-06
09421028111331Enztec Classic OCI – Corin Hex DriverENZTEC LIMITED39910550032026-01-06
09421028111362Enztec Classic OCI - Tornier TrinketENZTEC LIMITED39910770012026-01-06
09421028115643Enztec Classic OCI - Trinket 7 /16-20 UNF-02ENZTEC LIMITED4252-20992026-01-06
09421038410530Enztec Trinket M8x1.00-03ENZTEC LIMITED4252-23732026-01-05
09421038411612Offset Acetabular Shell Impactor Hex Driver - EnztecENZTEC LIMITED1080-0-15012025-12-19
09421038411629Offset Acetabular Shell Impactor Trinket - EnztecENZTEC LIMITED1080-0-15022025-12-19
09421038411643Offset Acetabular Shell Impactor - EnztecENZTEC LIMITED1080-0-17012025-12-19
09421038411667Enztec XR Trinket M8X1.25-01ENZTEC LIMITED4252-24442025-12-19
09421038411674Enztec XR Trinket 3/8-24 UNF-03ENZTEC LIMITED4252-24452025-12-19
09421038411681Enztec XR Trinket 7/16-20 UNF-01ENZTEC LIMITED4252-24462025-12-19
03662663216272Vital Spinal Fixation SystemHighridge Medical, LLC732M21212025-12-17
03662663216289Vital Spinal Fixation SystemHighridge Medical, LLC732M21242025-12-17
03662663216296Vital Spinal Fixation SystemHighridge Medical, LLC732M21262025-12-17
03662663216302Vital Spinal Fixation SystemHighridge Medical, LLC732M21292025-12-17
03662663191951Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC2000-90892025-12-16
M711LS2030Excella III-D®INNO Holdings, Inc.LS-2032019-07-05
08806373889622LOSPA Surgical InstrumentsCorentec Co., Ltd01.61.1522025-12-08
09309000394319MAC SurgicalMAC SURGICAL PTY LTDM01-457-5002025-12-01
10705034222783X-MESHDEPUY SPINE, LLC2889000202016-12-31
10705034222790X-MESHDEPUY SPINE, LLC2889000212016-12-31
10705034222806X-MESHDEPUY SPINE, LLC2889000222016-12-31
10705034222813X-MESHDEPUY SPINE, LLC2889000232016-12-31
08800017271194BENCOX Surgical InstrumentsCorentec Co., Ltd01.51.888.062025-11-24
08806373887840BENCOX Surgical InstrumentsCorentec Co., Ltd01.51.888.022025-11-24
08806373887857BENCOX Surgical InstrumentsCorentec Co., Ltd01.51.888.052025-11-24
08806373888038BENCOX Surgical InstrumentsCorentec Co., Ltd01.51.771.022025-11-24
00840338604071Tornier HRS MaxTORNIER, INC.ARS102562025-11-18
03662663215046Vital Spinal Fixation SystemHighridge Medical, LLC730M00302025-11-17
04055207068335VERTEBRISRichard Wolf GmbH8922015012025-11-17
03662663137188Polaris 4.75 Deformity SystemHighridge Medical, LLC14-5100732025-11-14
03662663280709Breckenridge ACDF SystemHighridge Medical, LLC8841-10002025-11-16
03662663280716Breckenridge ACDF SystemHighridge Medical, LLC8841-10012025-11-16
08033390287777ArTTLIMACORPORATE SPA9055.34.1012025-09-25
00810189110502IMPACTOR SHAFTOsteocentric Technologies, Inc.324-00222025-09-22
00810189110519IMPACTOR TIPOsteocentric Technologies, Inc.324-00322025-09-22
00843511122775Omnia Medical PSiFDNAOMNIA MEDICAL, LLC11-5P-IMP1-SS2025-09-22
00841731126054Hintermann Series VILEX LLCHT-399512025-09-17
00841731134257Hintermann Series VILEX LLCHT-394302025-09-17
00841731134301Hintermann Series VILEX LLCHT-395032025-09-17
00841731134318Hintermann Series VILEX LLCHT-395022025-09-17
00841731134325Hintermann Series VILEX LLCHT-393702025-09-17
00841731142344Hintermann Series VILEX LLCHT-396012025-09-17
00190446922780DJO SURGICALEncore Medical, L.P.S-2018602025-09-04
00190446922797DJO SURGICALEncore Medical, L.P.S-2018612025-09-04
09421038410349OCI X T-Handle Driver - S+NENZTEC LIMITED4252-23252025-09-03
09421038411216Enztec Straight Cup Impactor - CorinENZTEC LIMITED4252-24012025-09-03
09421038411483Enztec Trinket M10x1.50 - TruncatedENZTEC LIMITED4252-23762025-09-03
00889797112185Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.338290522025-08-26
00889797112475Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.338201912025-08-26
09348215117733Modular D-PadSIGNATURE ORTHOPAEDICS PTY LTD122-18-15522025-08-26
00822409131259N/AOrtho Development CorporationC-18322025-08-21
05055662970562ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDOS353506-NS2025-08-15
G079AOL1340Advantage -LUMBAR InterbodyIntelivation, LLCAOL-1342025-08-07
08054752862951PositionerADLER ORTHO SPAPositioner2025-08-05
08054752862982ImpactorADLER ORTHO SPAImpactor2025-08-05
08054752862999ImpactorADLER ORTHO SPAImpactor2025-08-05
08050507136407ImpactorADLER ORTHO SPAImpactor2025-08-04
08050507136414ImpactorADLER ORTHO SPAImpactor2025-08-04
08050507136421ImpactorADLER ORTHO SPAImpactor2025-08-04
08054752862975ImpactorADLER ORTHO SPAImpactor2025-08-04
08056269048118ImpactorADLER ORTHO SPAImpactor2025-08-04
08056269048286PositionerADLER ORTHO SPAPositioner2025-08-04
08056269048873ImpactorADLER ORTHO SPAImpactor2025-08-04
08056269049658ImpactorADLER ORTHO SPAImpactor2025-08-04
08056269049665ImpactorADLER ORTHO SPAImpactor2025-08-04
08056269049672ImpactorADLER ORTHO SPAImpactor2025-08-04
08056269049689ImpactorADLER ORTHO SPAImpactor2025-08-04
00194613017279MSI Precision Specialty InstrumentsMed Saver, Inc.E53772025-08-01