V-STRUT Vertebral Implant 36545

GUDID 03770007907387

V-STRUT© Vertebral Implant 6.5-L45

HYPREVENTION

Vertebral body prosthesis

• Primary Device ID: 03770007907387
• NIH Device Record Key: 079faf8b-1ee0-46b0-8015-f437f45e3588
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-STRUT Vertebral Implant
• Version Model Number: 36545
• Catalog Number: 36545
• Company DUNS: 262372421
• Company Name: HYPREVENTION
• 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

Device Dimensions

• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770007907387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191709

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

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: 2020-07-20
• Device Publish Date: 2020-07-10

On-Brand Devices [V-STRUT Vertebral Implant]

• 03770007907417: V-STRUT© Vertebral Implant 6.5-L60
• 03770007907400: V-STRUT© Vertebral Implant 6.5-L55
• 03770007907394: V-STRUT© Vertebral Implant 6.5-L50
• 03770007907387: V-STRUT© Vertebral Implant 6.5-L45
• 03770007907370: V-STRUT© Vertebral Implant 6.5-L40
• 03770007907363: V-STRUT© Vertebral Implant 5.5-L60
• 03770007907356: V-STRUT© Vertebral Implant 5.5-L55
• 03770007907349: V-STRUT© Vertebral Implant 5.5-L50
• 03770007907332: V-STRUT© Vertebral Implant 5.5-L45
• 03770007907325: V-STRUT© Vertebral Implant 5.5-L40
• 03770007907615: V-STRUT© Vertebral Implant 6.5-L60
• 03770007907608: V-STRUT© Vertebral Implant 6.5-L55
• 03770007907592: V-STRUT© Vertebral Implant 6.5-L50
• 03770007907585: V-STRUT© Vertebral Implant 6.5-L45
• 03770007907578: V-STRUT© Vertebral Implant 6.5-L40
• 03770007907561: V-STRUT© Vertebral Implant 5.5-L60
• 03770007907554: V-STRUT© Vertebral Implant 5.5-L55
• 03770007907547: V-STRUT© Vertebral Implant 5.5-L50
• 03770007907530: V-STRUT© Vertebral Implant 5.5-L45
• 03770007907523: V-STRUT© Vertebral Implant 5.5-L40
• 03770007907820: V-STRUT© Vertebral Implant 4.5-L55
• 03770007907813: V-STRUT© Vertebral Implant 4.5-L50
• 03770007907806: V-STRUT© Vertebral Implant 4.5-L45
• 03770007907790: V-STRUT© Vertebral Implant 4.5-L60
• 03770007907783: V-STRUT© Vertebral Implant 4.5-L40
• 03770007907776: V-STRUT© Vertebral Implant 4.5-L35
• 03770007907769: V-STRUT© Vertebral Implant 4.5-L30
• 03770007907752: V-STRUT© Vertebral Implant 4.5-L25