EXRAY35 HVP3513

GUDID 03701091001484

Self-compressive cannulated screw

ADSM

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03701091001484
• NIH Device Record Key: 9a48c5ac-9bcb-4d74-9e59-1c7eaabf8d6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXRAY35
• Version Model Number: HVP3513
• Catalog Number: HVP3513
• Company DUNS: 266749350
• Company Name: ADSM
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com
• Phone: +33428710310
• Email: office@synchromedical.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701091001484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151241

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-24
• Device Publish Date: 2020-12-16

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• 03701091001538: Self-compressive cannulated screw
• 03701091001521: Self-compressive cannulated screw
• 03701091001514: Self-compressive cannulated screw
• 03701091001507: Self-compressive cannulated screw
• 03701091001491: Self-compressive cannulated screw
• 03701091001484: Self-compressive cannulated screw
• 03701091001477: Self-compressive cannulated screw