Pedimax II - Pedicular Screw Spinal System 152-70-35

GUDID 07899258614106

PEDIMAX II PERCUTANEOUS POLYAXIAL PEDICLE SCREW Ø7.0x35.0mm

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 07899258614106
• NIH Device Record Key: 2f922d28-1a6f-468e-8fe5-e2f6d18efbb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedimax II - Pedicular Screw Spinal System
• Version Model Number: Polyaxial Pedicle Screw
• Catalog Number: 152-70-35
• Company DUNS: 900865213
• Company Name: GM DOS REIS INDUSTRIA E COMERCIO LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07899258614106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180626

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

[07899258614106]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-26
• Device Publish Date: 2024-01-18

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

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