DVX5.5 SPINE SYSTEM

GUDID 08809228126576

Rod, Ø5.5 x 130mm

BK MEDITECH CO.,LTD.

Bone-screw internal spinal fixation system rod

• Primary Device ID: 08809228126576
• NIH Device Record Key: ad4569d5-de5c-4531-aaca-c6071bedeb4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVX5.5 SPINE SYSTEM
• Version Model Number: 82120-13
• 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	08809228126576 [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

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

Moist Heat or Steam Sterilization

[08809228126576]

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 [DVX5.5 SPINE SYSTEM]

• 08809228126668: Cross-Link, 55mm
• 08809228126651: Cross-Link, 50mm
• 08809228126644: Cross-Link, 45mm
• 08809228126637: Cross-Link, 40mm
• 08809228126620: Rod, Ø5.5 x 400mm
• 08809228126613: Rod, Ø5.5 x 300mm
• 08809228126606: Rod, Ø5.5 x 200mm
• 08809228126590: Rod, Ø5.5 x 180mm
• 08809228126583: Rod, Ø5.5 x 160mm
• 08809228126576: Rod, Ø5.5 x 130mm
• 08809228126569: Rod, Ø5.5 x 120mm
• 08809228126552: Rod, Ø5.5 x 110mm
• 08809228126545: Rod, Ø5.5 x 100mm
• 08809228126538: Rod, Ø5.5 x 90mm
• 08809228126521: Rod, Ø5.5 x 80mm
• 08809228126514: Rod, Ø5.5 x 70mm
• 08809228126507: Rod, Ø5.5 x 60mm
• 08809228126491: Rod, Ø5.5 x 50mm
• 08809228126484: Rod, Ø5.5 x 40mm
• 08809228126477: Rod, Ø5.5 x 35mm
• 08809228126460: Locking Cap
• 08809228126453: Multi-axial Pedicle Screw, Ø7.5 x 60mm
• 08809228126446: Multi-axial Pedicle Screw, Ø7.5 x 55mm
• 08809228126439: Multi-axial Pedicle Screw, Ø7.5 x 50mm
• 08809228126422: Multi-axial Pedicle Screw, Ø7.5 x 45mm
• 08809228126415: Multi-axial Pedicle Screw, Ø7.5 x 40mm
• 08809228126408: Multi-axial Pedicle Screw, Ø7.5 x 35mm
• 08809228126392: Multi-axial Pedicle Screw, Ø7.0 x 50mm
• 08809228126385: Multi-axial Pedicle Screw, Ø7.0 x 45mm
• 08809228126378: Multi-axial Pedicle Screw, Ø7.0 x 40mm
• 08809228126361: Multi-axial Pedicle Screw, Ø7.0 x 35mm
• 08809228126354: Multi-axial Pedicle Screw, Ø6.5 x 60mm
• 08809228126347: Multi-axial Pedicle Screw, Ø6.5 x 55mm
• 08809228126330: Multi-axial Pedicle Screw, Ø6.5 x 50mm
• 08809228126323: Multi-axial Pedicle Screw, Ø6.5 x 45mm
• 08809228126316: Multi-axial Pedicle Screw, Ø6.5 x 40mm
• 08809228126309: Multi-axial Pedicle Screw, Ø6.5 x 35mm
• 08809228126293: Multi-axial Pedicle Screw, Ø6.0 x 50mm
• 08809228126286: Multi-axial Pedicle Screw, Ø6.0 x 45mm
• 08809228126279: Multi-axial Pedicle Screw, Ø6.0 x 40mm
• 08809228126262: Multi-axial Pedicle Screw, Ø6.0 x 35mm
• 08809228126255: Multi-axial Pedicle Screw, Ø6.0 x 30mm
• 08809228126248: Multi-axial Pedicle Screw, Ø5.5 x 60mm
• 08809228126231: Multi-axial Pedicle Screw, Ø5.5 x 55mm
• 08809228126224: Multi-axial Pedicle Screw, Ø5.5 x 50mm
• 08809228126217: Multi-axial Pedicle Screw, Ø5.5 x 45mm
• 08809228126200: Multi-axial Pedicle Screw, Ø5.5 x 40mm
• 08809228126194: Multi-axial Pedicle Screw, Ø5.5 x 35mm
• 08809228126187: Multi-axial Pedicle Screw, Ø5.0 x 45mm
• 08809228126170: Multi-axial Pedicle Screw, Ø5.0 x 40mm