AccelFix Spinal Fixation System 2302-65150

GUDID 08800061316483

Percutaneous Poly Screw Open Type Ø6.5 , 150mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08800061316483
NIH Device Record Key6ff2d856-1cb1-4e1b-bc51-1c8e6a18b2b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccelFix Spinal Fixation System
Version Model Number2302-65150
Catalog Number2302-65150
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
GS108800061316483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800061316483]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

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