FDA.reportPublic FDA data

Spinal rod bending system

Definition
An assembly of mains electricity (AC-powered) computerized devices intended to be used to determine the relative locations of internal spinal fixation system implants (e.g., screws, hooks) for the production of bend instructions to shape a spinal rod during spinal fusion surgery. It primarily consists of an electronic spatial measurement system used with manual tools to determine implant location and to take measurements; computer/software to convert implant locations to a series of bend instructions; and an orthopaedic rod bender to execute bend instructions. This is a reusable device.
GUDID devices
31
Last updated
2025-05-02 13:10:23

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07649994217013Neo ADVISEComerge AGR2.X.Y2025-04-24
00887517695505NuVaMapNuvasive, Inc.82103472024-04-05
00887517707291NuVaMapNuvasive, Inc.82103482024-04-05
B07315K0122100NIDO Pedicle Screw SystemKalitec Direct LLC15-K01-22102023-10-06
B07315K0430200NIDO Pedicle Screw SystemKalitec Direct LLC15-K04-30202023-10-06
B07315K0430210NIDO Pedicle Screw SystemKalitec Direct LLC15-K04-30212023-10-06
00190376394428InvictusALPHATEC SPINE, INC.17060-N2022-04-30
00887517605054BendiniNuvasive, Inc.82103122018-09-21
00887517605078BendiniNuvasive, Inc.82103142018-09-21
00887517672261BendiniNuvasive, Inc.82103182018-09-24
00887517757142ReLineNuvasive, Inc.100010492017-05-17
00887517141132BendiniNuvasive, Inc.15787872019-07-15
00887517246837BendiniNuvasive, Inc.15707802019-07-15
B07311K0130130CosmoLock Pedicle Screw SystemKalitec Direct LLC11-K01-30132018-09-18
B07311K0130140CosmoLock Pedicle Screw SystemKalitec Direct LLC11-K01-30142018-09-18
B07311K0130190Cosmolock Pedicle Screw SystemKalitec Direct LLC11-K01-30192018-09-18
B07311K0150020CosmoLock Pedicle Screw SystemKalitec Direct LLC11-K01-50022018-09-19
B07311K0150030CosmoLock Pedicle Screw SystemKalitec Direct LLC11-K01-50032018-09-19
B07311K0330060CosmoLock Pedicle Screw SystemKalitec Direct LLC11-K03-30062018-09-18
B07311K0330150CosmoLock Pedicle Screw SystemKalitec Direct LLC11-K03-30152018-09-18
B07311K0330160CosmoLock Pedicle Screw SystemKalitec Direct LLC11-K03-30162018-09-18
B07311K0730060CosmoLock Pedicle Screw SystemKalitec Direct LLC11-K07-30062018-09-18
00887517094698BendiniNuvasive, Inc.82100102016-10-11
00887517107787BendiniNuvasive, Inc.82103002016-10-11
00887517172532BendiniNuvasive, Inc.20400012016-09-26
00887517193957BendiniNuvasive, Inc.82103062016-09-26
00887517270207BendiniNuvasive, Inc.82103012016-09-26
00887517285263BendiniNuvasive, Inc.82100052016-09-26
00887517285270BendiniNuvasive, Inc.82100062016-09-26
00887517285287BendiniNuvasive, Inc.82100072016-09-26
00887517285294BendiniNuvasive, Inc.82100082016-09-26