LnK Spinal Fixation System 1302-0000

GUDID 08806189800064

L&K Biomed Set Screw-Hex for 6.0 Rod 9.7x5.6mm 1EA

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08806189800064
NIH Device Record Key475e32f4-5c39-4630-9d8f-7e07e41f32fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameLnK Spinal Fixation System
Version Model Number1302-0000
Catalog Number1302-0000
Company DUNS631159324
Company NameL&K BIOMED CO. ,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806189800064 [Primary]

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806189800064]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-10
Device Publish Date2015-05-14

On-Brand Devices [LnK Spinal Fixation System]

08806189835622L&K Biomed Rod, Straight, CoCrMo 6.0x100mm 1EA
08806189837879L&K Biomed Rod, Straight, Hex, Titanium 5.5x130mm 1EA
08806189837855L&K Biomed Rod, Straight, Hex, Titanium 5.5x120mm 1EA
08806189837848L&K Biomed Rod, Straight, Hex, Titanium 5.5x115mm 1EA
08806189837831L&K Biomed Rod, Straight, Hex, Titanium 5.5x110mm 1EA
08806189837824L&K Biomed Rod, Straight, Hex, Titanium 5.5x105mm 1EA
08806189837817L&K Biomed Rod, Straight, Hex, Titanium 5.5x100mm 1EA
08806189800071L&K Biomed Set Screw-Star for 6.0 Rod 9.7x5.6mm 1EA
08806189800064L&K Biomed Set Screw-Hex for 6.0 Rod 9.7x5.6mm 1EA
08806189841500L&K Biomed Rod, Straight, Hex, CoCrMo 6.0x120mm 1EA
08806189837534L&K Biomed Rod, Straight, Hex, Titanium 5.0x450mm 1EA
08806189835783L&K Biomed Rod, Straight, CoCrMo 6.0x180mm 1EA
08806189823438L&K Biomed Reductionn Poly Axial Screw 4.5x20mm 1EA
08806189821793L&K Biomed Poly Axial Screw 5.0x45mm 1EA
08806189810643L&K Biomed Reductionn Mono Axial Screw 6.0x60mm 1EA
08806189810636L&K Biomed Reductionn Mono Axial Screw 6.0x55mm 1EA
08806189810629L&K Biomed Reductionn Mono Axial Screw 6.0x50mm 1EA
08806189810612L&K Biomed Reductionn Mono Axial Screw 6.0x45mm 1EA
08806189810605L&K Biomed Reductionn Mono Axial Screw 6.0x40mm 1EA
08806189810599L&K Biomed Reductionn Mono Axial Screw 6.0x35mm 1EA
08806189810582L&K Biomed Reductionn Mono Axial Screw 6.0x30mm 1EA
08806189810575L&K Biomed Reductionn Mono Axial Screw 6.0x25mm 1EA
08806189810568L&K Biomed Reductionn Mono Axial Screw 6.0x20mm 1EA
08806189804819L&K Biomed Mono Axial Iliac Screw 6.5x80mm 1EA
08806189835332L&K Biomed Rod, Straight, CoCrMo 6.0x440mm 1EA
08806189832065L&K Biomed Rod, Straight, Titanium 5.5x145mm 1EA
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