OrthoSolutions 'System26' Bone Screws OS918085-NS

GUDID 05055662951196

6.5MM X 85MM HEADLESS CANNULATED SCREW FULLY THREADED

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID05055662951196
NIH Device Record Keyb3c78407-9c29-43bf-a006-c159ba122080
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoSolutions 'System26' Bone Screws
Version Model NumberOS918085-NS
Catalog NumberOS918085-NS
Company DUNS218648211
Company NameORTHO SOLUTIONS HOLDINGS LIMITED
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055662951196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055662951196]

Moist Heat or Steam Sterilization


[05055662951196]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-21