AccelFix Spinal Fixation System 2302-9095

GUDID 08800061317626

Percutaneous Poly Screw Open Type Ø9.0 , 95mm

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08800061317626
NIH Device Record Keyf0f9e6c8-50a3-4490-bd4f-a542e4cbf860
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccelFix Spinal Fixation System
Version Model Number2302-9095
Catalog Number2302-9095
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
GS108800061317626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800061317626]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-06
Device Publish Date2020-03-29

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