UNI-THREAD®

GUDID 03663136005867

Ti 6.5mm x 40mm Right Rod Connector

SPINEVISION

Bone-screw internal spinal fixation system connector
Primary Device ID03663136005867
NIH Device Record Key41fe309d-83f9-4bc9-a90a-dd63404a2552
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNI-THREAD®
Version Model NumberL2-RC604RT
Company DUNS390377518
Company NameSPINEVISION
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS103663136005867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


[03663136005867]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-12-20
Device Publish Date2015-10-15

On-Brand Devices [UNI-THREAD®]

03663136027258Upper Arm
03663136027135BLADE HOLDER 2
03663136020044Ti 6.5mm x 120mm Right Reduction Rod Connector
03663136020006Ti 6.5mm x 60mm Right Reduction Rod Connector
03663136006222Ti 5.5 mm x 33-38mm threaded reduction screw,6.5mm top
03663136005867Ti 6.5mm x 40mm Right Rod Connector
03663136005584Ti 6.0 mm x 80 mm pre-bent rod

Trademark Results [UNI-THREAD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNI-THREAD
UNI-THREAD
78297801 3065015 Live/Registered
Spinevision S.A.
2003-09-09

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.