NEOFIX

GUDID 07898624860925

4-Hole 3.5 Semi Tubular LS Plate

Neoortho Produtos Ortopédicos S/A.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 07898624860925
• NIH Device Record Key: d3e3bccc-f6f8-4dff-8a97-e11002b0cf9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEOFIX
• Version Model Number: 900.336
• Company DUNS: 914644351
• Company Name: Neoortho Produtos Ortopédicos S/A.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: +554135351000
• Email: sac@neoortho.com.br

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898624860925 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113733

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[07898624860925]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-19
• Device Publish Date: 2015-10-16

On-Brand Devices [NEOFIX]

• 07899893205424: Smooth Pin D2.4x40mm
• 07899893205417: Smooth Pin D2.4x38mm
• 07899893205400: Smooth Pin D2.4x36mm
• 07899893205394: Smooth Pin D2.4x34mm
• 07899893205387: Smooth Pin D2.4x32mm
• 07899893205370: Smooth Pin D2.4x30mm
• 07899893205356: Smooth Pin D2.4x28mm
• 07899893205349: Smooth Pin D2.4x26mm
• 07899893205332: Smooth Pin D2.4x24mm
• 07899893205325: Smooth Pin D2.4x22mm
• 07899893205318: Smooth Pin D2.4x20mm
• 07899893205301: Smooth Pin D2.4x18mm
• 07899893205295: Smooth Pin D2.4x17mm
• 07899893205288: Smooth Pin D2.4x16mm
• 07899893205271: Smooth Pin D2.4x15mm
• 07899893205264: Smooth Pin D2.4x14mm
• 07899893205257: Smooth Pin D2.4x13mm
• 07899893205240: Smooth Pin D2.4x12mm
• 07899893205233: Smooth Pin D2.4x11mm
• 07899893205226: Smooth Pin D2.4x10mm
• 07899893205219: Smooth Pin D2.4x9mm
• 07899893205202: Smooth Pin D2.4x8mm
• 07899893205196: Smooth Pin D2.4x7mm
• 07899893205189: Smooth Pin D2.4x6mm
• 07899893205172: Smooth Pin D2.4x5mm
• 07899893223237: Depth Measurer 4.5-6.5 mm
• 07899893231447: Extraction Instruments Container
• 07899893231430: Trochanteric Femoral Nail Implant Container - 2/2
• 07899893229376: Trochanteric Femoral Nail Instruments Container
• 07899893229369: Trochanteric Femoral Nail Implant Container - 1/2
• 07899893207237: Standard Cortical Screw D1.5x13 mm
• 07899893207213: Standard Cortical Screw D2.0x12 mm
• 07899893207169: Star Head Standard Cancellous Screw Ø 6.5 x 65 mm
• 07899893207152: Star Head Partial Thread Cancellous Screw Ø 4 x 14 mm
• 07899893207145: Star Head Self Drilling Locking Screw Ø 5x 45 mm
• 07899893207138: Star Head Self Drilling Locking Screw D3.5x42 mm
• 07899893207121: Star Head Self Drilling Locking Screw D3.5x40 mm
• 07899893207114: Star Head Self Drilling Locking Screw D3.5x35 mm
• 07899893207107: Star Head Locking Screw Ø 5.0 x 70 mm
• 07899893207091: Star Head Locking Screw Ø 5.0 x 65 mm
• 07899893207084: Star Head Locking Screw Ø 5.0 x 14 mm
• 07899893207077: 11-Hole 3.5 Straight LS Plate
• 07899893207060: 10-Hole 3.5 Straight LS Plate
• 07899893207053: 7-Hole 3.5 Straight LS Plate
• 07899893207046: 10-Hole 3.5 Reconstruction LS Plate
• 07899893207039: 6-Hole Left Clavicle LS Small Plate
• 07899893206230: Emergency Standard Cortical Screw D2.3x11mm
• 07899893206223: Emergency Standard Cortical Screw D2.3x9.0mm
• 07899893206216: Emergency Standard Cortical Screw D2.3x7.0mm
• 07899893206209: Emergency Standard Cortical Screw D2.3x5.0mm