Primary Device ID | 08800108623277 |
NIH Device Record Key | 0551c425-571d-4196-83b8-74fe5d686acf |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LnK/OpenLoc-L Spinal Fixation System |
Version Model Number | 1043-0054S |
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 | true |
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 | 08800108623277 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-12-23 |
Device Publish Date | 2020-12-15 |
08806344397149 | Crosslink 50-70mm |
08806344397132 | Crosslink 40-53mm |
08806344397125 | Crosslink 34-42mm |
08806344397118 | Crosslink 30-34mm |
08806344348288 | Mono Axial Screw Ø7.0, 70mm |
08806344348295 | Mono Axial Screw Ø7.0, 75mm |
08800108623277 | Crosslink46-54mm |
08800108623260 | Crosslink40-48mm |
08800108623253 | Crosslink34-42mm |
08800108623246 | Crosslink30-34mm |