AccelFix Lumbar Plate System 5015-1628

GUDID 08800061394382

AccelFix Lumbar Plate (2 Hole type), 28mm, Blue

L&K BIOMED CO. ,LTD.

Spinal fixation plate, non-bioabsorbable
Primary Device ID08800061394382
NIH Device Record Key177a4355-9407-4e72-902e-2bcb0061621d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccelFix Lumbar Plate System
Version Model Number5015-1628
Catalog Number5015-1628
Company DUNS631159324
Company NameL&K BIOMED CO. ,LTD.
Device Count1
DM Exempttrue
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
GS108800061394382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

[08800061394382]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-08
Device Publish Date2023-08-31

On-Brand Devices [AccelFix Lumbar Plate System]

08800061394436AccelFix Lumbar Plate (2 Hole type), 30mm, Blue
08800061394429AccelFix Lumbar Plate (2 Hole type), 28mm, Blue
08800061394412AccelFix Lumbar Plate (2 Hole type), 27mm, Blue
08800061394405AccelFix Lumbar Plate (2 Hole type), 26mm, Blue
08800061394399AccelFix Lumbar Plate (2 Hole type), 30mm, Blue
08800061394382AccelFix Lumbar Plate (2 Hole type), 28mm, Blue
08800061394375AccelFix Lumbar Plate (2 Hole type), 27mm, Blue
08800061394368AccelFix Lumbar Plate (2 Hole type), 26mm, Blue
08800061399974AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 45mm
08800061399967AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 40mm
08800061399950AccelFix Lumbar Plate Screw, (Variable type, dual thread), Pi6.0, 35mm
08800061399943AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), Pi6.0, 45mm
08800061399936AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), Pi6.0, 40mm
08800061399929AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 35mm
08800061644005AccelFix Lumbar Plate Screw,(Variable type, dual thread), pi6.0, 30mm
08800061643992AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi6.0, 25mm
08800061643985AccelFix Lumbar Plate Screw,(Variable type, dual thread), pi6.0, 20mm
08800061643923AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 30mm
08800061643916AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 25mm
08800061643909AccelFix Lumbar Plate Screw, (Variable type, dual thread), pi5.5, 20mm
08800061643688AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 30mm
08800061643671AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 25mm
08800061643664AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi6.0, 20mm
08800061643602AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 30mm
08800061643596AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 25mm
08800061643589AccelFix Lumbar Plate Screw, (Fixed type, Dual thread), pi5.5, 20mm
08800061644050AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 55mm
08800061644043AccelFix Lumbar Plate Screw,(Variable type, dual thread), Ø6.0, 50mm
08800061644036AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 45mm
08800061644029AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 40mm
08800061644012AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 35mm
08800061643978AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 55mm
08800061643961AccelFix Lumbar Plate Screw,(Variable type, dual thread), Ø5.5, 50mm
08800061643954AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 45mm
08800061643947AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 40mm
08800061643930AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 35mm
08800061642872AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 55mm
08800061642865AccelFix Lumbar Plate Screw,(Variable type, dual thread), Ø6.0, 50mm
08800061642858AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 45mm
08800061642841AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 40mm
08800061642834AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø6.0, 35mm
08800061642797AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 55mm
08800061642780AccelFix Lumbar Plate Screw,(Variable type, dual thread), Ø5.5, 50mm
08800061642773AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 45mm
08800061642766AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 40mm
08800061642759AccelFix Lumbar Plate Screw, (Variable type, dual thread), Ø5.5, 35mm
08800061644210AccelFix Lumbar Plate Screw, (Variable type, cancellous), Ø6.0, 55mm
08800061644203AccelFix Lumbar Plate Screw,(Variable type, cancellous), Ø6.0, 50mm
08800061644197AccelFix Lumbar Plate Screw, (Variable type, cancellous), Ø6.0, 45mm
08800061644180AccelFix Lumbar Plate Screw,(Variable type, cancellous Ø6.0, 40mm
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