FDA.reportPublic FDA data

Orthopaedic rod reducer

Definition
A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.
GUDID devices
911
Last updated
2026-10-04 01:44:28

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840606191340PrimusSPINAL ELEMENTS, INC.66722-0002026-09-22
07613327009040XIA 3Stryker Corporation482350012019-11-08
07613327114836XIA 4.5 EVOLUTIONStryker Corporation481380162019-11-08
07613327142303XIAStryker CorporationIS4037XLP2019-11-08
07613327262247XIAStryker Corporation038070192019-11-08
07613327263343XIAStryker Corporation480470162019-11-08
07613327264616XIA 4.5Stryker Corporation481370192019-11-08
07613327265422XIA 3Stryker Corporation482370162019-11-08
07613327265507XIA 3Stryker Corporation482370192019-11-08
07613327265637XIA 3Stryker Corporation482370152019-11-08
07613327266290MANTISStryker Corporation482800792019-11-08
07613327266764MANTISStryker Corporation482840662019-11-08
07613327266801MANTISStryker Corporation482840652019-11-08
07613327271157OASYSStryker Corporation485600242019-11-08
07613327271300OASYSStryker Corporation485610242019-11-08
07613327271683OASYSStryker Corporation485620242019-11-08
07613327275704XIA ELEGANCEStryker Corporation4823970162019-11-08
07613327276213RADIUSStryker Corporation4866191902019-11-08
07613327276381RADIUSStryker Corporation4866191802019-11-08
07613327464146OASYSStryker CorporationIS4390OAS012019-01-17
07613327480108Xia 3Stryker CorporationIS4500XLP2019-05-30
07613327500721Xia 3Stryker CorporationIS4478XLP2020-05-27
07613327503975OASYSStryker CorporationIS4528OAS012020-02-03
07613327503982OASYSStryker CorporationIS4528OAS022020-02-03
10888857009561DENALI Spinal SystemVB Spine LLC101-900232022-07-25
10888857039810EVEREST Spinal SystemVB Spine LLC2901-900102022-08-06
10888857039827EVEREST Spinal SystemVB Spine LLC2901-900112022-08-06
10888857040663EVEREST Spinal SystemVB Spine LLC2901-901102022-08-06
10888857052918MESA Small Stature Spinal SystemVB Spine LLC3001-900852022-08-06
10888857052925MESA Small Stature Spinal SystemVB Spine LLC3001-900862022-08-06
10888857053090MESA Small Stature Spinal SystemVB Spine LLC3001-901052022-08-06
10888857053106MESA Small Stature Spinal SystemVB Spine LLC3001-901062022-08-06
10888857053113MESA Small Stature Spinal SystemVB Spine LLC3001-901072022-08-06
10888857053250MESA Small Stature Spinal SystemVB Spine LLC3001-901212022-08-06
10888857053380MESA Small Stature Spinal SystemVB Spine LLC3001-901342022-08-06
10888857053403MESA Small Stature Spinal SystemVB Spine LLC3001-901362022-08-06
10888857053519MESA Small Stature Spinal SystemVB Spine LLC3001-901482022-08-06
10888857104006EVEREST Spinal SystemVB Spine LLC5101-900122022-08-09
10888857104044EVEREST Spinal SystemVB Spine LLC5101-900162022-08-09
10888857143098MESA Spinal SystemVB Spine LLC801-900382022-08-05
10888857143272MESA Spinal SystemVB Spine LLC801-900662022-08-05
10888857143708MESA Spinal SystemVB Spine LLC801-901472022-08-06
10888857279391EVEREST Spinal SystemVB Spine LLC5101-901602022-08-09
10888857279438EVEREST Spinal SystemVB Spine LLC5101-901792022-08-09
10888857309005MESA Spinal SystemVB Spine LLC801-902152022-08-06
10888857313309MESA Spinal SystemVB Spine LLC6201-900862022-05-31
10888857313316MESA Spinal SystemVB Spine LLC6201-900872022-05-31
10888857313347MESA Spinal SystemVB Spine LLC6201-900882022-05-31
10888857320468MESA Spinal SystemVB Spine LLC6201-900842022-05-31
10888857323698MESA Spinal SystemVB Spine LLC6201-900852022-05-31
10888857325975EVEREST Spinal SystemVB Spine LLC5101-902192022-08-09
10888857401242OZARK Cervical Plate SystemVB Spine LLC8801-900732022-05-31
10888857553477K2M General InstrumentsVB Spine LLCPRO-1232-012023-02-16
10888857560437YUKON OCT Spinal SystemVB Spine LLCPRO-13142022-10-28
10888857562141EVEREST Spinal SystemVB Spine LLCPRO-13012023-04-12
10888857562301EVEREST Spinal SystemVB Spine LLCPRO-1304-012023-04-26
10888857562318EVEREST Spinal SystemVB Spine LLCPRO-1304-022023-04-26
10888857562769K2M General InstrumentsVB Spine LLCPRO-13362023-09-08
10888857578357Vulcan™ Spinal SystemVB Spine LLC8042-902372026-02-20
10888857578746Vulcan™ Spinal SystemVB Spine LLC8042-902552026-02-20
10888857578753Vulcan™ Spinal SystemVB Spine LLC8042-902562026-02-20
10888857596665EVEREST® Spinal SystemVB Spine LLCPRO-14232026-03-25
M719GSIX1210TiLockGenesys Orthopedics Systems LLC12026-08-18
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.33020-0002026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.33021-0002026-07-31
10889981182717MarinerSeaspine Orthopedics Corporation90-06072019-10-24
00841732125162GENERIC Surgical InstrumentsCTL Medical Corporation119.70722019-10-18
00841732125179GENERIC Surgical InstrumentsCTL Medical Corporation119.70712019-10-18
00841732127937GENERIC Surgical InstrumentsCTL Medical Corporation119.70792019-10-18
00841732127944GENERIC Surgical InstrumentsCTL Medical Corporation119.70802019-10-18
00841732129788GENERIC Surgical InstrumentsCTL Medical Corporation119.70772023-09-15
00841732141087PICASSO II MIS Spinal SystemCTL Medical Corporation119.71722023-09-15
00841732141094PICASSO II MIS Spinal SystemCTL Medical Corporation119.71702023-09-15
00190376147925InvictusALPHATEC SPINE, INC.160332020-06-17
00190376196114InvictusALPHATEC SPINE, INC.170322020-06-17
00190376204666InvictusALPHATEC SPINE, INC.171322020-06-17
00199150069682Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.EX11250072026-04-23
00763000256371n/aMEDTRONIC SOFAMOR DANEK, INC.55991002020-11-06
00763000256388n/aMEDTRONIC SOFAMOR DANEK, INC.55991012020-11-06
00763000256395n/aMEDTRONIC SOFAMOR DANEK, INC.55991022020-11-06