MEGA PLUS MIS SPINE SYSTEM

GUDID 08809916496066

Long-arm Multi-Axial Fenestrated Screw, Ø4.5 x 45mm, Ø5.5mm Rod

BK MEDITECH CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID08809916496066
NIH Device Record Keya5354eaa-b066-4bc7-a8e5-0165e64e88fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEGA PLUS MIS SPINE SYSTEM
Version Model Number98545-45
Company DUNS687941818
Company NameBK MEDITECH 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809916496066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

[08809916496066]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

On-Brand Devices [MEGA PLUS MIS SPINE SYSTEM]

08809763491887MIS Deformity Rod(CoCr), Ø6.0 x 250.5mm
08809763491870MIS Deformity Rod(CoCr), Ø6.0 x 230.5mm
08809763491863MIS Deformity Rod(CoCr), Ø6.0 x 210.5mm
08809763491856MIS Deformity Rod(CoCr), Ø6.0 x 190.5mm
08809763491849MIS Deformity Rod(CoCr), Ø6.0 x 170.5mm
08809763491788MIS Pre-Bent Rod(CoCr), Ø6.0 x 510.5mm
08809763491771MIS Pre-Bent Rod(CoCr), Ø6.0 x 460.5mm
08809763491764MIS Pre-Bent Rod(CoCr), Ø6.0 x 410.5mm
08809763491757MIS Pre-Bent Rod(CoCr), Ø6.0 x 360.5mm
08809763491740MIS Pre-Bent Rod(CoCr), Ø6.0 x 310.5mm
08809763491733MIS Pre-Bent Rod(CoCr), Ø6.0 x 300.5mm
08809763491726MIS Pre-Bent Rod(CoCr), Ø6.0 x 290.5mm
08809763491719MIS Pre-Bent Rod(CoCr), Ø6.0 x 280.5mm
08809763491702MIS Pre-Bent Rod(CoCr), Ø6.0 x 270.5mm
08809763491696MIS Pre-Bent Rod(CoCr), Ø6.0 x 260.5mm
08809763491689MIS Pre-Bent Rod(CoCr), Ø6.0 x 250.5mm
08809763491672MIS Pre-Bent Rod(CoCr), Ø6.0 x 240.5mm
08809763491665MIS Pre-Bent Rod(CoCr), Ø6.0 x 230.5mm
08809763491658MIS Pre-Bent Rod(CoCr), Ø6.0 x 220.5mm
08809763491641MIS Pre-Bent Rod(CoCr), Ø6.0 x 210.5mm
08809763491634MIS Pre-Bent Rod(CoCr), Ø6.0 x 200.5mm
08809763491627MIS Pre-Bent Rod(CoCr), Ø6.0 x 190.5mm
08809763491610MIS Pre-Bent Rod(CoCr), Ø6.0 x 180.5mm
08809763491603MIS Pre-Bent Rod(CoCr), Ø6.0 x 170.5mm
08809763491597MIS Pre-Bent Rod(CoCr), Ø6.0 x 160.5mm
08809763491580MIS Pre-Bent Rod(CoCr), Ø6.0 x 150.5mm
08809763491573MIS Pre-Bent Rod(CoCr), Ø6.0 x 140.5mm
08809763491566MIS Pre-Bent Rod(CoCr), Ø6.0 x 130.5mm
08809763491559MIS Pre-Bent Rod(CoCr), Ø6.0 x 120.5mm
08809763491542MIS Pre-Bent Rod(CoCr), Ø6.0 x 110.5mm
08809763491535MIS Pre-Bent Rod(CoCr), Ø6.0 x 105.5mm
08809763491528MIS Pre-Bent Rod(CoCr), Ø6.0 x 100.5mm
08809763491511MIS Pre-Bent Rod(CoCr), Ø6.0 x 95.5mm
08809763491504MIS Pre-Bent Rod(CoCr), Ø6.0 x 90.5mm
08809763491498MIS Pre-Bent Rod(CoCr), Ø6.0 x 85.5mm
08809763491481MIS Pre-Bent Rod(CoCr), Ø6.0 x 80.5mm
08809763491474MIS Pre-Bent Rod(CoCr), Ø6.0 x 75.5mm
08809763491467MIS Pre-Bent Rod(CoCr), Ø6.0 x 70.5mm
08809763491450MIS Pre-Bent Rod(CoCr), Ø6.0 x 65.5mm
08809763491443MIS Pre-Bent Rod(CoCr), Ø6.0 x 60.5mm
08809763491436MIS Pre-Bent Rod(CoCr), Ø6.0 x 55.5mm
08809763491429MIS Pre-Bent Rod(CoCr), Ø6.0 x 50.5mm
08809763491412MIS Pre-Bent Rod(CoCr), Ø6.0 x 45.5mm
08809763491405MIS Pre-Bent Rod(CoCr), Ø6.0 x 40.5mm
08809763491399MIS Pre-Bent Rod(CoCr), Ø6.0 x 35.5mm
08809763491382MIS Pre-Bent Rod(CoCr), Ø6.0 x 30.5mm
08809763491375MIS Pre-Bent Rod(CoCr), Ø6.0 x 25.5mm
08809763490941MIS Rod(CoCr), Ø6.0 x 510.5mm
08809763490934MIS Rod(CoCr), Ø6.0 x 460.5mm
08809763490927MIS Rod(CoCr), Ø6.0 x 410.5mm
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