Primary Device ID | 08809228126156 |
NIH Device Record Key | 8ff26dc5-e971-454f-a669-2f5bacb77e39 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DVX5.5 SPINE SYSTEM |
Version Model Number | 82150-30 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 08809228126156 [Primary] |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
[08809228126156]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2024-08-26 |
Device Publish Date | 2015-09-22 |
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 |