FDA.reportPublic FDA data

Orthopaedic bone-fragment manipulator, reusable

Definition
A hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a reusable device.
GUDID devices
245
Last updated
2026-09-04 23:09:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B382SD914775290Surgical DirectSurgical Direct, Inc.SD914775292026-08-21
B382SD91466911090Surgical DirectSurgical Direct, Inc.SD91466911092026-07-27
B382SD9147761000Surgical DirectSurgical Direct, Inc.SD9147761002026-07-27
B382SD9141551000Surgical DirectSurgical Direct, Inc.SD9141551002026-07-24
00888867504677Arthrex®ARTHREX, INC.AR-9953-052026-05-21
04048551114582n.a.Karl Storz GmbH & Co. KG28729PJ2019-02-23
04048551176979n.a.Karl Storz GmbH & Co. KG58900G2018-09-04
08032909627813EBA2CITIEFFE SRLFracture alignment guide wire exchange tool2016-09-24
08032909629749DINAMIC T HUMERUSCITIEFFE SRLFracture alignment and guide wire exchange tool2016-09-24
08052990976409ESTREMOCITIEFFE SRLCompaction device2019-02-07
08052990979745ESTREMOCITIEFFE SRLFracture alignment guide wire exchange tool2019-02-07
08059386742181Orthopaedic Surgical InstrumentsCITIEFFE SRLFracture reduction wire (AO coupling)2025-11-05
08059386744406Orthopaedic Surgical InstrumentsCITIEFFE SRLFracture align. guide wire exchange tool2025-11-06
10886982005229NASynthes GmbHSD324.0232016-12-31
10886982005236NASYNTHES (U.S.A.) LPSD324.0242016-12-31
10886982005243NASynthes GmbHSD324.0262016-12-31
10886982190062NASynthes GmbH319.1862016-12-31
10887587014159NASynthes GmbH03.507.0022016-12-31
10887587014173NASynthes GmbH03.507.0032016-12-31
10887587014180NASynthes GmbH03.507.0042016-12-31
B382SD1477840000Surgical DirectSurgical Direct, Inc.SD14778-40002025-10-06
M209209310Crocodile Reduction ForcepsBIOPRO, INC.209312017-08-13
M209209320Small Reduction ForcepsBIOPRO, INC.209322017-08-13
M209209330Medium Reduction ForcepsBIOPRO, INC.209332017-08-13
B382SD1477910050Surgical DirectSurgical Direct, Inc.SD14779-10052025-12-10
B382SD1477920000Surgical DirectSurgical Direct, Inc.SD14779-20002025-12-10
B382SD90176110000Surgical DirectSurgical Direct, Inc.SD901761-10002025-12-10
B382SD91475810000Surgical DirectSurgical Direct, Inc.SD914758-10002025-12-10
B382SD91477110000Surgical DirectSurgical Direct, Inc.SD914771-10002025-12-10
00841731142481Hintermann Series VILEX LLCHT-390102025-09-12
B382SD9147370100Surgical DirectSurgical Direct, Inc.SD9147370102025-09-12
B382SD9147370110Surgical DirectSurgical Direct, Inc.SD9147370112025-09-12
B382SD9147370120Surgical DirectSurgical Direct, Inc.SD9147370122025-09-12
B382SD147791160Surgical DirectSurgical Direct, Inc.SD14779-1162025-07-23
B382SD914155150Surgical DirectSurgical Direct, Inc.SD914155152025-07-23
B382SD914155160Surgical DirectSurgical Direct, Inc.SD914155162025-07-23
B382SD914155170Surgical DirectSurgical Direct, Inc.SD914155172025-07-23
B382SD914155190Surgical DirectSurgical Direct, Inc.SD914155192025-07-23
B382SD9147531000Surgical DirectSurgical Direct, Inc.SD9147531002025-07-23
B382SD914895110Surgical DirectSurgical Direct, Inc.SD914895112025-07-23
B382SD1472420000Surgical DirectSurgical Direct, Inc.SD14724-20002025-07-09
B382SD1477910040Surgical DirectSurgical Direct, Inc.SD14779-10042025-07-02
B382SD14569510010Surgical DirectSurgical Direct, Inc.SD145695-10012025-05-12
B382SD90115521150Surgical DirectSurgical Direct, Inc.SD90115521152025-05-12
B382SD91478110000Surgical DirectSurgical Direct, Inc.SD914781-10002025-03-17
B382SD9147791060Surgical DirectSurgical Direct, Inc.SD9147791062024-12-05
B382SD14569510000Surgical DirectSurgical Direct, Inc.SD145695-10002024-11-25
08059386743478Orthopaedic Surgical InstrumentsCITIEFFE SRLCompaction device2024-11-22
B382SD914156990Surgical DirectSurgical Direct, Inc.SD914156992024-10-22
08059386743072Orthopaedic Surgical InstrumentsCITIEFFE SRLFracture align. guide wire exchange tool, Hudson2024-09-10
00194613074319MSI Precision Specialty InstrumentsMed Saver, Inc.336286J2024-08-15
00194613079253MSI Precision Specialty InstrumentsMed Saver, Inc.D70562024-08-15
00194613079260MSI Precision Specialty InstrumentsMed Saver, Inc.D70622024-08-15
00194613079277MSI Precision Specialty InstrumentsMed Saver, Inc.D70642024-08-15
00194613079284MSI Precision Specialty InstrumentsMed Saver, Inc.D70682024-08-15
00194613079291MSI Precision Specialty InstrumentsMed Saver, Inc.D70702024-08-15
00194613079321MSI Precision Specialty InstrumentsMed Saver, Inc.D70782024-08-15
00194613079338MSI Precision Specialty InstrumentsMed Saver, Inc.D70802024-08-15
00194613079345MSI Precision Specialty InstrumentsMed Saver, Inc.D70822024-08-15
00194613079352MSI Precision Specialty InstrumentsMed Saver, Inc.D70842024-08-15
00194613079369MSI Precision Specialty InstrumentsMed Saver, Inc.D70902024-08-15
00194613079376MSI Precision Specialty InstrumentsMed Saver, Inc.D70922024-08-15
00194613079383MSI Precision Specialty InstrumentsMed Saver, Inc.D70942024-08-15
00194613079390MSI Precision Specialty InstrumentsMed Saver, Inc.D70962024-08-15
00194613079406MSI Precision Specialty InstrumentsMed Saver, Inc.D70982024-08-15
00194613079437MSI Precision Specialty InstrumentsMed Saver, Inc.D71092024-08-15
00194613079444MSI Precision Specialty InstrumentsMed Saver, Inc.D71142024-08-15
00194613079451MSI Precision Specialty InstrumentsMed Saver, Inc.D71162024-08-15
00194613079468MSI Precision Specialty InstrumentsMed Saver, Inc.D71202024-08-15
00194613079505MSI Precision Specialty InstrumentsMed Saver, Inc.D71392024-08-15
00194613079512MSI Precision Specialty InstrumentsMed Saver, Inc.D72022024-08-15
00194613079529MSI Precision Specialty InstrumentsMed Saver, Inc.D72042024-08-15
00194613079536MSI Precision Specialty InstrumentsMed Saver, Inc.D72062024-08-15
00194613079543MSI Precision Specialty InstrumentsMed Saver, Inc.D72082024-08-15
00194613079666MSI Precision Specialty InstrumentsMed Saver, Inc.D73702024-08-15
00194613079673MSI Precision Specialty InstrumentsMed Saver, Inc.D73982024-08-15
00194613079680MSI Precision Specialty InstrumentsMed Saver, Inc.D74062024-08-15
00194613079697MSI Precision Specialty InstrumentsMed Saver, Inc.D74122024-08-15
00194613079871MSI Precision Specialty InstrumentsMed Saver, Inc.D75502024-08-15
08059386742501ESTREMOCITIEFFE SRLFracture alignment guide wire exchange tool2024-07-16