Primary Device ID | 08806189800989 |
NIH Device Record Key | 6aa80a13-64c3-4771-bcdb-523f0012452f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LnK Spinal Fixation System |
Version Model Number | 1311-5555 |
Catalog Number | 1311-5555 |
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 | 08806189800989 [Primary] |
NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
[08806189800989]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-07-16 |
Device Publish Date | 2014-10-31 |
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08806189837879 | L&K Biomed Rod, Straight, Hex, Titanium 5.5x130mm 1EA |
08806189837855 | L&K Biomed Rod, Straight, Hex, Titanium 5.5x120mm 1EA |
08806189837848 | L&K Biomed Rod, Straight, Hex, Titanium 5.5x115mm 1EA |
08806189837831 | L&K Biomed Rod, Straight, Hex, Titanium 5.5x110mm 1EA |
08806189837824 | L&K Biomed Rod, Straight, Hex, Titanium 5.5x105mm 1EA |
08806189837817 | L&K Biomed Rod, Straight, Hex, Titanium 5.5x100mm 1EA |
08806189800071 | L&K Biomed Set Screw-Star for 6.0 Rod 9.7x5.6mm 1EA |
08806189800064 | L&K Biomed Set Screw-Hex for 6.0 Rod 9.7x5.6mm 1EA |
08806189841500 | L&K Biomed Rod, Straight, Hex, CoCrMo 6.0x120mm 1EA |
08806189837534 | L&K Biomed Rod, Straight, Hex, Titanium 5.0x450mm 1EA |
08806189835783 | L&K Biomed Rod, Straight, CoCrMo 6.0x180mm 1EA |
08806189823438 | L&K Biomed Reductionn Poly Axial Screw 4.5x20mm 1EA |
08806189821793 | L&K Biomed Poly Axial Screw 5.0x45mm 1EA |
08806189810643 | L&K Biomed Reductionn Mono Axial Screw 6.0x60mm 1EA |
08806189810636 | L&K Biomed Reductionn Mono Axial Screw 6.0x55mm 1EA |
08806189810629 | L&K Biomed Reductionn Mono Axial Screw 6.0x50mm 1EA |
08806189810612 | L&K Biomed Reductionn Mono Axial Screw 6.0x45mm 1EA |
08806189810605 | L&K Biomed Reductionn Mono Axial Screw 6.0x40mm 1EA |
08806189810599 | L&K Biomed Reductionn Mono Axial Screw 6.0x35mm 1EA |
08806189810582 | L&K Biomed Reductionn Mono Axial Screw 6.0x30mm 1EA |
08806189810575 | L&K Biomed Reductionn Mono Axial Screw 6.0x25mm 1EA |
08806189810568 | L&K Biomed Reductionn Mono Axial Screw 6.0x20mm 1EA |
08806189804819 | L&K Biomed Mono Axial Iliac Screw 6.5x80mm 1EA |
08806189835332 | L&K Biomed Rod, Straight, CoCrMo 6.0x440mm 1EA |
08806189832065 | L&K Biomed Rod, Straight, Titanium 5.5x145mm 1EA |
08806344320529 | General Hook, Standard, 11mm |
08806189867203 | L&K Biomed Poly Lateral Connector, Closed L1:36, L2:20, W:12,D:6 1EA |
08806189867067 | L&K Biomed Lateral Connector, Open, Knurling L1:44, L2:30, W:10,D1:6 1EA |
08806189866404 | L&K Biomed Lateral Connector, Closed, Hex L1:31, L2:20, W:10,D1:6 1EA |
08806189865797 | L&K Biomed Side Click Connector, Two by two L:22, W:8, D1:5.7,D2:6.5 1EA |
08806189865735 | L&K Biomed Side Click Connector, Two by two L:22, W:8, D1:5.2,D2:5.2 1EA |
08806189865544 | L&K Biomed Side Click Connector, Two by two L:20, W:8, D1:5.2,D2:5.7 1EA |
08806189865483 | L&K Biomed Side Click Connector, Two by two L:19, W:8, D1:5.7,D2:6.2 1EA |
08806189864790 | L&K Biomed Side Click Connector, One by two L:20, W:8, D1:5.7,D2:6.5 1EA |
08806189864745 | L&K Biomed Side Click Connector, One by two L:20, W:8, D1:5.2,D2:5.7 1EA |
08806189864486 | L&K Biomed Side Click Connector, One by one L:27, W:9, D1:5.7,D2:6.2 1EA |
08806189863946 | L&K Biomed Side Click Connector, One by one L:23, W:8, D1:5.2,D2:5.7 1EA |
08806189861577 | L&K Biomed Rod, Curved, Double Stopper, CoCrMo 6.0x135mm 1EA |
08806189860822 | L&K Biomed Rod, Curved, Double Stopper, Titanium 6.35x105mm 1EA |
08806189860624 | L&K Biomed Rod, Curved, Double Stopper, Titanium 6.0x120mm 1EA |
08806189860105 | L&K Biomed Rod, Curved, Double Stopper, Titanium 5.0x90mm 1EA |
08806189859925 | L&K Biomed Rod, Curved, Stopper, CoCrMo 6.35x115mm 1EA |
08806189859529 | L&K Biomed Rod, Curved, Stopper, CoCrMo 5.5x145mm 1EA |
08806189859239 | L&K Biomed Rod, Curved, Stopper, CoCrMo 5.0x115mm 1EA |
08806189858942 | L&K Biomed Rod, Curved, Stopper, Titanium 6.35x85mm 1EA |
08806189858911 | L&K Biomed Rod, Curved, Stopper, Titanium 6.35x70mm 1EA |
08806189858874 | L&K Biomed Rod, Curved, Stopper, Titanium 6.35x50mm 1EA |
08806189858492 | L&K Biomed Rod, Curved, Stopper, Titanium 5.5x90mm 1EA |
08806189858287 | L&K Biomed Rod, Curved, Stopper, Titanium 5.0x100mm 1EA |