Rexious BT.MS.55045

GUDID 08800113937451

Rexious Spinal Fixtion System - Mono-Axial Pedicle E Type (Single & Self Tapping) (L1)63x(L2)45x(A)5.5x(B)13.5mm-Ø6.0

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable
Primary Device ID08800113937451
NIH Device Record Key65092bc2-4034-40ac-9897-7fbf8548b20e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRexious
Version Model NumberA
Catalog NumberBT.MS.55045
Company DUNS557795909
Company NameDIOMEDICAL CO.,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com
Phone+82313699470
Emailinfo@huvexel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800113937451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

[08800113937451]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-31
Device Publish Date2021-05-21

On-Brand Devices [Rexious]

08800039872348Open connector (open 5.5 Domino - 10° 2hole 16mm)
08800039872331Open connector (open 5.5 Domino - 10° 2hole 12mm)
08800039872324Open connector (open 5.5 Domino - 0° 2hole 16mm)
08800039872317Open connector (open 5.5 Domino - 0° 2hole 12mm)
08800039872300Tapper 4.5
08800039872294Lareral Connetcor Open L45
08800039870504Lateral Connector Open L55
08800039842174CoCr Straight Rod D5.5 x 600mm
08800039834100Rod A type (Straight) 6.0 x 30mm
08800039834094Rod B type (Curved) 6.0 x 30mm
08800039830652TOWER REDUCER
08800039830584Rod C type (MIS) 5.5 X 150mm
08800039829809CROSSLINK CURVED CROSS CONNECTOR (Large)
08800039829793CROSSLINK CURVED CROSS CONNECTOR (Medium)
08800039829786CROSSLINK CURVED CROSS CONNECTOR (Xsmall)
08800039829779POLY AXIAL LATERAL CONNECTOR 30mm
08800039829762POLY AXIAL LATERAL CONNECTOR 15mm
08800039828826CoCr Straight Rod D5.5 x 195mm
08800039828819CoCr Straight Rod D5.5 x 190mm
08800039828802CoCr Straight Rod D5.5 x 185mm
08800039828796CoCr Straight Rod D5.5 x 180mm
08800039828789CoCr Straight Rod D5.5 x 175mm
08800039828772CoCr Straight Rod D5.5 x 170mm
08800039828765CoCr Straight Rod D5.5 x 165mm
08800039828758CoCr Straight Rod D5.5 x 160mm
08800039828741CoCr Straight Rod D5.5 x 155mm
08800039828734CoCr Straight Rod D5.5 x 150mm
08800039828727CoCr Straight Rod D5.5 x 145mm
08800039828710CoCr Straight Rod D5.5 x 140mm
08800039828703CoCr Straight Rod D5.5 x 135mm
08800039828697CoCr Straight Rod D5.5 x 130mm
08800039828680CoCr Straight Rod D5.5 x 125mm
08800039828673CoCr Straight Rod D5.5 x 120mm
08800039828666CoCr Straight Rod D5.5 x 115mm
08800039828659CoCr Straight Rod D5.5 x 110mm
08800039828642CoCr Straight Rod D5.5 x 105mm
08800039828635CoCr Straight Rod D5.5 x 100mm
08800039828628CoCr Straight Rod D5.5 x 95mm
08800039828611CoCr Straight Rod D5.5 x 90mm
08800039828604CoCr Straight Rod D5.5 x 85mm
08800039828598CoCr Straight Rod D5.5 x 80mm
08800039828581CoCr Straight Rod D5.5 x 75mm
08800039828574CoCr Straight Rod D5.5 x 70mm
08800039828567CoCr Straight Rod D5.5 x 65mm
08800039828550CoCr Straight Rod D5.5 x 60mm
08800039828543CoCr Straight Rod D5.5 x 55mm
08800039828536CoCr Straight Rod D5.5 x 50mm
08800039828529CoCr Straight Rod D5.5 x 45mm
08800039828512CoCr Straight Rod D5.5 x 40mm
08800039828505CoCr Straight Rod D5.5 x 35mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.