Pedimax II - Pedicular Screw Spinal System 112-06-210

GUDID 07899258617336

ROD Ø6.0 x 210.0mm

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID07899258617336
NIH Device Record Key7482d1a3-7c14-4be6-8bc8-ef43ba31f46b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePedimax II - Pedicular Screw Spinal System
Version Model NumberRod
Catalog Number112-06-210
Company DUNS900865213
Company NameGM DOS REIS INDUSTRIA E COMERCIO LTDA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899258617336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

[07899258617336]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-29
Device Publish Date2024-01-19

On-Brand Devices [Pedimax II - Pedicular Screw Spinal System]

07899258657707ROD TO ROD CLAMP Ø6.0 / 6.0mm LEFT
07899258657691ROD TO ROD CLAMP Ø6.0 / 6.0mm RIGHT
07899258649795PERCUTANEOUS ROD Ø6.0x90.0mm
07899258649788PERCUTANEOUS ROD Ø6.0x80.0mm
07899258649771PERCUTANEOUS ROD Ø6.0x55.0mm
07899258649566ROD TO ROD CLAMP Ø6.0 / 4.5mm LEFT
07899258649559ROD TO ROD CLAMP Ø6.0 / 4.5mm RIGHT
07899258627120ROD TO ROD CLAMP Ø3,5 / 6,0mm RIGHT
07899258623108ROD TO ROD CLAMP Ø3,5 / 6,0mm LEFT
07899258659435PEDIMAX II POLYAXIAL PEDICLE SCREWØ5.5x55.0mm
07899258657684PEDIMAX II PERCUTANEOUS LOCKING NUT
07899258649764PERCUTANEOUS ROD Ø6.0x50.0mm
07899258636412PEDIMAX II LOCKING NUT
07899258625393TRANSVERSAL ROD Ø3.2x100.0mm
07899258625386TRANSVERSAL ROD Ø3.2x80.0mm
07899258625379TRANSVERSAL ROD Ø3.2x60.0mm
07899258625362PEDIMAX II CROSSLINK CLAMP
07899258617367ROD Ø6.0 x 450.0mm
07899258614403PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREW Ø7.0x50.0mm
07899258614380PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREW Ø7.0x40.0mm
07899258614373PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREW Ø7.0x35.0mm
07899258614366PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREW Ø7.0x30.0mm
07899258614359PEDIMAX II SPONDYLOLISTHESIS SCREWØ6.2x50.0mm
07899258614342PEDIMAX II SPONDYLOLISTHESIS SCREWØ6.2x45.0mm
07899258614335PEDIMAX II SPONDYLOLISTHESIS SCREWØ6.2x40.0mm
07899258614328PEDIMAX II SPONDYLOLISTHESIS SCREWØ6.2x35.0mm
07899258614311PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREWØ5.5x50.0mm
07899258614304PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREWØ5.5x45.0mm
07899258614298PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREWØ5.5x40.0mm
07899258614281PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREWØ5.5x35.0mm
07899258614274PEDIMAX II SPONDYLOLISTHESIS POLYAXIAL PEDICLE SCREWØ5.5x30.0mm
07899258614267PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x50.0mm
07899258614250PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x45.0mm
07899258614243PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x40.0mm
07899258614236PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x35.0mm
07899258614229PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x30.0mm
07899258614212PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø6.2x50.0mm
07899258614205PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø6.2x45.0mm
07899258614199PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø6.2x40.0mm
07899258614182PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø6.2x35.0mm
07899258614175PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø5.5x45.0mm
07899258614168PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø5.5x40.0mm
07899258614151PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø5.5x35.0mm
07899258614144PEDIMAX II SPONDYLOLISTHESIS PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø5.5x30.0mm
07899258614137PEDIMAX II PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x50.0mm
07899258614120PEDIMAX II PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x45.0mm
07899258614113PEDIMAX II PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x40.0mm
07899258614106PEDIMAX II PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x35.0mm
07899258614090PEDIMAX II PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x30.0mm
07899258614083PEDIMAX II PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø6.2x50.0mm
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