PCT PCT08ACMED

GUDID 00840402512585

Variable Cross Connector, Medium

Silony Medical Corp

Bone-screw internal spinal fixation system connector

• Primary Device ID: 00840402512585
• NIH Device Record Key: ad645d36-9640-40b4-b8e4-7e08893763d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCT
• Version Model Number: PCT08ACMED
• Catalog Number: PCT08ACMED
• Company DUNS: 106081213
• Company Name: Silony Medical Corp
• 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: false
• Expiration Date: false
• 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	00815101028088 [Previous]
GS1	00840402512585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152211

FDA Product Code

• NKG: Posterior cervical screw system

Sterilization

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

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

[00840402512585]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

On-Brand Devices [PCT]

• 00840402512639: Fixed Cross Connector, 24mm
• 00840402512615: Fixed Cross Connector, 22mm
• 00840402512608: Variable Cross Connector, Extra Large
• 00840402512585: Variable Cross Connector, Medium
• 00840402512578: Variable Cross Connector, Large
• 00840402512561: Lateral Offset Connector, 18mm
• 00840402512523: Lateral Offset Connector, 14mm
• 00840402512486: Lateral Offset Connector, 10mm
• 00840402512431: Domino Connector, 8mm
• 00840402512363: Straight Hook, 6mm
• 00840402512271: Flat Set Screw
• 00840402512264: Domed Set Screw
• 00840402511908: 4.0mm Pre-Lordosed Rod,70mm
• 00840402511861: 4.0mm Pre-Lordosed Rod,50mm
• 00840402511489: 3.5mm Pre-Lordosed Rod,80mm
• 00840402511465: 3.5mm Pre-Lordosed Rod,70mm
• 00840402511441: 3.5mm Pre-Lordosed Rod,60mm
• 00840402511427: 3.5mm Pre-Lordosed Rod,50mm
• 00840402511120: 4.0mm Straight Rod,120mm
• 00840402510680: 3.5mm Straight Rod,120mm
• 00840402510048: 4.0mm Polyaxial Screw,Smooth Shank,36mm
• 00840402510024: 4.0mm Polyaxial Screw,Smooth Shank,34mm
• 00840402509981: 4.0mm Polyaxial Screw,Smooth Shank,30mm
• 00840402509967: 4.0mm Polyaxial Screw,Smooth Shank,28mm
• 00840402509943: 4.0mm Polyaxial Screw,Smooth Shank,26mm
• 00840402509929: 4.0mm Polyaxial Screw,Smooth Shank,24mm
• 00840402509578: 3.5mm Polyaxial Screw,Smooth Shank,20mm
• 00840402509448: 4.5mm Polyaxial Screw,38mm
• 00840402509400: 4.5mm Polyaxial Screw,34mm
• 00840402509363: 4.5mm Polyaxial Screw,30mm
• 00840402509325: 4.5mm Polyaxial Screw,26mm
• 00840402509288: 4.5mm Polyaxial Screw,22mm
• 00840402509264: 4.5mm Polyaxial Screw,20mm
• 00840402508939: 4.0mm Polyaxial Screw,28mm
• 00840402508830: 4.0mm Polyaxial Screw,18mm
• 00840402508755: 4.0mm Polyaxial Screw,10mm
• 00840402508489: 3.5mm Polyaxial Screw,24mm
• 00840402508441: 3.5mm Polyaxial Screw,20mm
• 00840402508427: 3.5mm Polyaxial Screw,18mm
• 00840402508403: 3.5mm Polyaxial Screw,16mm
• 00840402508380: 3.5mm Polyaxial Screw,14mm