FDA.reportPublic FDA data

Orthopaedic surgical distractor, internal

Definition
A hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.
GUDID devices
3,462
Last updated
2026-10-04 01:44:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00613994404510Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X07061942022-10-07
00613994507129Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X08081362022-10-07
00613994507150Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X08081392022-10-07
00613994507174Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X08081412022-10-07
00613994872555Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.X06102742022-10-07
00643169046139N/AMEDTRONIC SOFAMOR DANEK, INC.X07114162022-08-07
00643169046191N/AMEDTRONIC SOFAMOR DANEK, INC.X07114102022-08-07
00643169046207N/AMEDTRONIC SOFAMOR DANEK, INC.X07114092022-08-07
00643169046221N/AMEDTRONIC SOFAMOR DANEK, INC.X07114072022-08-07
00643169671249N/AMEDTRONIC SOFAMOR DANEK, INC.X06150322017-10-13
00643169671256N/AMEDTRONIC SOFAMOR DANEK, INC.X06150332017-12-17
00840606191357PrimusSPINAL ELEMENTS, INC.66732-0002026-09-22
07613327006919ES2 SPINAL SYSTEMStryker Corporation482800822019-11-20
07613327006926ES2 SPINAL SYSTEMStryker Corporation482800832019-11-20
07613327132731XIA 4.5 System - XIA CTStryker Corporation488560102016-01-18
07613327262254XIAStryker Corporation038070152019-11-20
07613327262469VBOSSStryker Corporation336603102019-11-20
07613327262483VBOSSStryker Corporation336603302019-11-20
07613327262506VBOSSStryker Corporation336603502019-11-20
07613327262520VBOSSStryker Corporation336603402019-11-20
07613327262551VBOSSStryker Corporation336603202019-11-20
07613327263077XIA ANTERIORStryker Corporation480402442018-09-24
07613327264692XIA 4.5Stryker Corporation481361002019-11-20
07613327265323XIA 3Stryker Corporation482360002019-11-20
07613327265347XIA 3Stryker Corporation482360012019-11-20
07613327265361XIA 3Stryker Corporation482361002019-11-20
07613327265446XIA 3Stryker Corporation482361012019-11-20
07613327266405ES2 SPINAL SYSTEMStryker Corporation482801802019-11-20
07613327267372AVS Anchor-C Cervical Cage SystemStryker Corporation483287252019-11-20
07613327268898RELIANCE ALStryker Corporation483611542018-09-24
07613327268904RELIANCE ALStryker Corporation483611522018-09-24
07613327268928RELIANCEStryker Corporation483611502018-09-24
07613327268935RELIANCE ALStryker Corporation483611552018-09-24
07613327268942RELIANCE ALStryker Corporation483611582018-09-24
07613327269048RELIANCE ALStryker Corporation483611572018-09-24
07613327269062RELIANCEStryker Corporation483612202018-09-24
07613327271089DYNATRANStryker Corporation485150192019-11-20
07613327271324OASYSStryker Corporation485610262019-11-20
07613327272130ARIAStryker Corporation487582102019-11-20
07613327272147ARIAStryker Corporation487582162019-11-20
07613327272161ARIAStryker Corporation487582122019-11-20
07613327272178ARIAStryker Corporation487582182019-11-20
07613327272185ARIAStryker Corporation487582082019-11-20
07613327272260ARIAStryker Corporation487582142019-11-20
07613327273274TRIOStryker Corporation489060412019-11-20
07613327273885Aero-LLStryker Corporation489420042019-11-20
07613327276435RADIUSStryker Corporation4866193802019-11-20
07613327276527RADIUSStryker Corporation4866193902019-11-20
07613327279689TRIOStryker CorporationIS3001TRI2019-11-20
10888857001336DENALI MI Spinal SystemVB Spine LLC1001-901772022-08-09
10888857001343DENALI MI Spinal SystemVB Spine LLC1001-901782022-08-09
10888857020214TERRA NOVA MI Access SystemVB Spine LLC1501-900142022-06-01
10888857023314SANTORINI™ Corpectomy Cage SystemVB Spine LLC1708-900102018-12-10
10888857030602PYRENEES® Cervical Plate SystemVB Spine LLC201-902532021-04-02
10888857030619PYRENEES® Cervical Plate SystemVB Spine LLC201-902542021-04-02
10888857040465EVEREST Spinal SystemVB Spine LLC2901-900872022-08-06
10888857040472EVEREST Spinal SystemVB Spine LLC2901-900882022-08-06
10888857052888MESA Small Stature Spinal SystemVB Spine LLC3001-900822022-08-06
10888857052970MESA Small Stature Spinal SystemVB Spine LLC3001-900922022-08-06
10888857053427MESA Small Stature Spinal SystemVB Spine LLC3001-901392022-08-06
10888857075870ALEUTIAN Interbody SystemsVB Spine LLC3303-900782022-07-11
10888857104129EVEREST Spinal SystemVB Spine LLC5101-900262022-08-09
10888857128163ALEUTIAN Interbody SystemsVB Spine LLC702-902282022-07-12
10888857143036MESA Spinal SystemVB Spine LLC801-900262022-08-05
10888857143043MESA® Spinal SystemVB Spine LLC801-900272021-12-09
10888857143050MESA® Spinal SystemVB Spine LLC801-900282021-12-09
10888857143142MESA Spinal SystemVB Spine LLC801-900512022-08-05
10888857143432MESA Spinal SystemVB Spine LLC801-901182022-08-05
10888857143449MESA Spinal SystemVB Spine LLC801-901192022-08-06
10888857143692MESA Spinal SystemVB Spine LLC801-901462022-08-05
10888857171541MESA Spinal SystemVB Spine LLC801-902082022-08-06
10888857230569SANTORINI™ Corpectomy Cage SystemVB Spine LLCK2-17-2004-012021-03-25
10888857241961PYRENEES® Cervical Plate SystemVB Spine LLCK2-02-2309-012021-04-02
10888857241978PYRENEES® Cervical Plate SystemVB Spine LLCK2-02-2314-012021-04-02
10888857303775EVEREST Spinal SystemVB Spine LLC2901-901852022-08-06
10888857381759EVEREST Spinal SystemVB Spine LLC5101-902522022-08-09
10888857381766EVEREST Spinal SystemVB Spine LLC5101-902532022-08-09
10888857431683EVEREST® Spinal SystemVB Spine LLC5101-902672020-03-25
00885556837825Total Foot System 2Smith & Nephew, Inc.3820002022-12-22
00840606186414ALIFSPINAL ELEMENTS, INC.15166-0002026-08-26