FDA.reportPublic FDA data

Orthopaedic fixation plate tensioner

Definition
A hand-held manual surgical instrument designed to apply tension to an orthopaedic implant (typically a fixation plate) to compress a fracture site prior to final fixation of the implant. It is typically designed with two adjustable legs, one terminating with an anchoring loop that is attached to intact bone and the other terminating with a claw that is attached to the implant which has been fixed to one side of the fracture site; after device placement the fracture is compressed through manual operation of a device mechanism (e.g., turning a central screw). It is typically made of high-grade stainless steel and may be used on simple or compound fractures. This is a reusable device.
GUDID devices
115
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00887868047633TENSIONERBiomet Orthopedics, LLC8180-50-0002020-05-23
00887868047640TENSIONER HEAD, CANNULATEDBiomet Orthopedics, LLC8180-50-0012020-05-23
00887868047657TENSIONER HEAD, OFFSETBiomet Orthopedics, LLC8180-50-0022020-05-23
00887868047664TENSIONER HEAD, ANCHORBiomet Orthopedics, LLC8180-50-0042020-05-23
04042409396533LOQTEQ®aap Implantate AGIU 8175-502018-02-28
10705034507712VIPER PRIMEMedos International Sàrl2867500812017-05-18
10705034507729VIPER PRIMEMedos International Sàrl2867500822017-05-18
10705034507736VIPER PRIMEMedos International Sàrl2867500832017-05-18
10886982003713DCSSynthes GmbHSD280.9902016-12-31
10886982004420NASYNTHES (U.S.A.) LPSD312.1202016-12-31
10886982005090NASynthes GmbHSD321.1202016-12-31
10886982005106NASynthes GmbHSD321.1212016-12-31
10886982005113NASynthes GmbHSD321.1222016-12-31
10886982006615NASynthes GmbHSD393.7602016-12-31
10886982073334NASynthes GmbH03.118.0042016-12-31
10886982073341NASynthes GmbH03.118.0052016-12-31
10886982073358NASynthes GmbH03.118.0062016-12-31
10886982073372NASynthes GmbH03.118.0082016-12-31
10886982190369NASynthes GmbH321.122016-12-31
10886982190376NASynthes GmbH321.1212016-12-31
00888233076357RIBFIX TITANBIOMET MICROFIXATION, INC323.80202024-09-09
00888233076364RIBFIX TITANBIOMET MICROFIXATION, INC323.80212024-09-09
00888233076371RIBFIX TITANBIOMET MICROFIXATION, INC323.80222024-09-09
00888233076388RIBFIX TITANBIOMET MICROFIXATION, INC323.80232024-09-09
00810028397835EF1Medshape, Inc.DNE-9000-ST2024-07-09
00190776343309MILLENNIUMAvalign Technologies, Inc.0-479112023-09-28
03596010031921ILIZAROVSmith & Nephew, Inc.1030982017-11-13
00190776265113AvalignAvalign Technologies, Inc.VM80-18592023-06-23
00846832095452Made-To-OrderTORNIER, INC.90272012022-12-02
00846832095469Made-To-OrderTORNIER, INC.90272022022-12-02
00846832095476Made-To-OrderTORNIER, INC.90272032022-12-02
00846832095483Made-To-OrderTORNIER, INC.90272042022-12-02
00846832095490Made-To-OrderTORNIER, INC.90272052022-12-02
00846832095506Made-To-OrderTORNIER, INC.90272062022-12-02
00846832095513Made-To-OrderTORNIER, INC.90272072022-12-02
00846832095520Made-To-OrderTORNIER, INC.90272082022-12-02
00846832095926Made-To-OrderTORNIER, INC.90272722022-12-02
00846832095933Made-To-OrderTORNIER, INC.90272732022-12-02
00846832095940Made-To-OrderTORNIER, INC.90272742022-12-02
00846832095957Made-To-OrderTORNIER, INC.90272752022-12-02
00846832095964Made-To-OrderTORNIER, INC.90272762022-12-02
00846832095971Made-To-OrderTORNIER, INC.90272772022-12-02
00846832097012Made-To-OrderTORNIER, INC.90273852022-12-02
00846832097029Made-To-OrderTORNIER, INC.90273862022-12-02
00846832097036Made-To-OrderTORNIER, INC.90273872022-12-02
00846832097043Made-To-OrderTORNIER, INC.90273882022-12-02
00846832097050Made-To-OrderTORNIER, INC.90273892022-12-02
00846832097067Made-To-OrderTORNIER, INC.90273902022-12-02
00846832097074Made-To-OrderTORNIER, INC.90273912022-12-02
00846832097081Made-To-OrderTORNIER, INC.90273922022-12-02
00846832097098Made-To-OrderTORNIER, INC.90273932022-12-02
00846832097104Made-To-OrderTORNIER, INC.90273942022-12-02
00846832097111Made-To-OrderTORNIER, INC.90273952022-12-02
00846832097128Made-To-OrderTORNIER, INC.90273962022-12-02
00846832097135Made-To-OrderTORNIER, INC.90273972022-12-02
00846832097142Made-To-OrderTORNIER, INC.90273982022-12-02
00840314246509gSourceGSOURCE LLCgS 86.72202020-03-03
00846832000944StabilisTORNIER, INC.AFPCOMPR2022-08-09
00846832010462MaxLockTORNIER, INC.ANK-0682022-08-09
03700386970870Aequalis Resurfacing HeadTORNIERMWB4902022-08-08
03700386970887Aequalis Resurfacing HeadTORNIERMWB4912022-08-08
03700386970894Aequalis Resurfacing HeadTORNIERMWB4922022-08-08
03700386977107Tornier FlexTORNIERMWF601S2022-08-08
03700386977121Tornier FlexTORNIERMWF602S2022-08-08
03700386977145Tornier FlexTORNIERMWF603S2022-08-08
03700386977169Tornier FlexTORNIERMWF604S2022-08-08
03700386977183Tornier FlexTORNIERMWF605S2022-08-08
03700386977206Tornier FlexTORNIERMWF606S2022-08-08
03700386977220Tornier FlexTORNIERMWF607S2022-08-08
03700386977244Tornier FlexTORNIERMWF608S2022-08-08
03700386977268Tornier FlexTORNIERMWF611S2022-08-08
03700386977282Tornier FlexTORNIERMWF612S2022-08-08
03700386977305Tornier FlexTORNIERMWF613S2022-08-08
03700386977329Tornier FlexTORNIERMWF614S2022-08-08
03700386977343Tornier FlexTORNIERMWF615S2022-08-08
03700386977367Tornier FlexTORNIERMWF616S2022-08-08
03700386977381Tornier FlexTORNIERMWF617S2022-08-08
03700386977404Tornier FlexTORNIERMWF618S2022-08-08
H679321120NASynthes GmbH321.122016-12-31
H6793211210NASynthes GmbH321.1212016-12-31