| Primary Device ID | 08800061642834 |
| NIH Device Record Key | 6d01b5b3-2fd6-4f99-934f-affd5cdf71f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccelFix Lumbar Plate System |
| Version Model Number | 7302-6035 |
| Catalog Number | 7302-6035 |
| Company DUNS | 631159324 |
| Company Name | L&K BIOMED 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800061642834 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
[08800061642834]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-06 |
| Device Publish Date | 2024-12-27 |
| 08800061394436 | AccelFix Lumbar Plate (2 Hole type), 30mm, Blue |
| 08800061394429 | AccelFix Lumbar Plate (2 Hole type), 28mm, Blue |
| 08800061394412 | AccelFix Lumbar Plate (2 Hole type), 27mm, Blue |
| 08800061394405 | AccelFix Lumbar Plate (2 Hole type), 26mm, Blue |
| 08800061394399 | AccelFix Lumbar Plate (2 Hole type), 30mm, Blue |
| 08800061394382 | AccelFix Lumbar Plate (2 Hole type), 28mm, Blue |
| 08800061394375 | AccelFix Lumbar Plate (2 Hole type), 27mm, Blue |
| 08800061394368 | AccelFix Lumbar Plate (2 Hole type), 26mm, Blue |
| 08800061399974 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 45mm |
| 08800061399967 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 40mm |
| 08800061399950 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 35mm |
| 08800061399943 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), Pi6.0, 45mm |
| 08800061399936 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), Pi6.0, 40mm |
| 08800061399929 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 35mm |
| 08800061644005 | AccelFix Lumbar Plate Screw,(Variable type, dual thread), pi6.0, 30mm |
| 08800061643992 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi6.0, 25mm |
| 08800061643985 | AccelFix Lumbar Plate Screw,(Variable type, dual thread), pi6.0, 20mm |
| 08800061643923 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 30mm |
| 08800061643916 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 25mm |
| 08800061643909 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 20mm |
| 08800061643688 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 30mm |
| 08800061643671 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 25mm |
| 08800061643664 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 20mm |
| 08800061643602 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 30mm |
| 08800061643596 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 25mm |
| 08800061643589 | AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 20mm |
| 08800061644050 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 55mm |
| 08800061644043 | AccelFix Lumbar Plate Screw,(Variable type, dual thread), Ø6.0, 50mm |
| 08800061644036 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 45mm |
| 08800061644029 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 40mm |
| 08800061644012 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 35mm |
| 08800061643978 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 55mm |
| 08800061643961 | AccelFix Lumbar Plate Screw,(Variable type, dual thread), Ø5.5, 50mm |
| 08800061643954 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 45mm |
| 08800061643947 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 40mm |
| 08800061643930 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 35mm |
| 08800061642872 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 55mm |
| 08800061642865 | AccelFix Lumbar Plate Screw,(Variable type, dual thread), Ø6.0, 50mm |
| 08800061642858 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 45mm |
| 08800061642841 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 40mm |
| 08800061642834 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 35mm |
| 08800061642797 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 55mm |
| 08800061642780 | AccelFix Lumbar Plate Screw,(Variable type, dual thread), Ø5.5, 50mm |
| 08800061642773 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 45mm |
| 08800061642766 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 40mm |
| 08800061642759 | AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 35mm |