DVX SPINE SYSTEM

GUDID 08809155852388

Pre-bent Rod, Ø6.0 x 35mm

BK MEDITECH CO.,LTD.

Bone-screw internal spinal fixation system rod

• Primary Device ID: 08809155852388
• NIH Device Record Key: d81d0c6e-6b54-4c1e-8c18-0ef8df480af2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVX SPINE SYSTEM
• Version Model Number: 61121-035
• Company DUNS: 687941818
• Company Name: BK MEDITECH CO.,LTD.
• 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	08809155852388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090424

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

[08809155852388]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-26
• Device Publish Date: 2015-09-22

On-Brand Devices [DVX SPINE SYSTEM]

• 08809155854672: Rod, Ø6.0 x 300mm
• 08809155854665: Rod, Ø6.0 x 200mm
• 08809155854658: Rod, Ø6.0 x 150mm
• 08809155854641: Rod, Ø6.0 x 110mm
• 08809155854634: Rod, Ø6.0 x 90mm
• 08809155854627: Rod, Ø6.0 x 70mm
• 08809155854610: Rod, Ø6.0 x 60mm
• 08809155854603: Rod, Ø6.0 x 50mm
• 08809155854597: Rod, Ø6.0 x 40mm
• 08809155852593: Cross-Link, 55mm
• 08809155852586: Cross-Link, 50mm
• 08809155852579: Cross-Link, 45mm
• 08809155852562: Cross-Link, 40mm
• 08809155852555: Cross-Link, 35mm
• 08809155852470: Pre-bent Rod, Ø6.0 x 100mm
• 08809155852463: Pre-bent Rod, Ø6.0 x 90mm
• 08809155852456: Pre-bent Rod, Ø6.0 x 80mm
• 08809155852449: Pre-bent Rod, Ø6.0 x 70mm
• 08809155852432: Pre-bent Rod, Ø6.0 x 60mm
• 08809155852425: Pre-bent Rod, Ø6.0 x 55mm
• 08809155852418: Pre-bent Rod, Ø6.0 x 50mm
• 08809155852401: Pre-bent Rod, Ø6.0 x 45mm
• 08809155852395: Pre-bent Rod, Ø6.0 x 40mm
• 08809155852388: Pre-bent Rod, Ø6.0 x 35mm
• 08809155852289: Locking Cap
• 08809155852272: Multi-axial Pedicle Screw, Ø7.5 x 60mm
• 08809155852265: Multi-axial Pedicle Screw, Ø7.5 x 55mm
• 08809155852258: Multi-axial Pedicle Screw, Ø7.5 x 50mm
• 08809155852241: Multi-axial Pedicle Screw, Ø7.5 x 45mm
• 08809155852234: Multi-axial Pedicle Screw, Ø7.5 x 40mm
• 08809155852227: Multi-axial Pedicle Screw, Ø7.5 x 35mm
• 08809155852203: Multi-axial Pedicle Screw, Ø6.5 x 60mm
• 08809155852197: Multi-axial Pedicle Screw, Ø6.5 x 55mm
• 08809155852180: Multi-axial Pedicle Screw, Ø6.5 x 50mm
• 08809155852173: Multi-axial Pedicle Screw, Ø6.5 x 45mm
• 08809155852166: Multi-axial Pedicle Screw, Ø6.5 x 40mm
• 08809155852159: Multi-axial Pedicle Screw, Ø6.5 x 35mm
• 08809155852135: Multi-axial Pedicle Screw, Ø5.5 x 60mm
• 08809155852128: Multi-axial Pedicle Screw, Ø5.5 x 55mm
• 08809155852111: Multi-axial Pedicle Screw, Ø5.5 x 50mm
• 08809155852104: Multi-axial Pedicle Screw, Ø5.5 x 45mm
• 08809155852098: Multi-axial Pedicle Screw, Ø5.5 x 40mm
• 08809155852081: Multi-axial Pedicle Screw, Ø5.5 x 35mm