OrthoSolutions 'System26' Bone Screws OS917100-NS

GUDID 05055662960228

6.5MM X 100MM HEADLESS CANNULATED SCREW 33MM THREAD

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID05055662960228
NIH Device Record Keyd2cd3317-bace-44de-a510-8c9903dfc580
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoSolutions 'System26' Bone Screws
Version Model NumberOS917100-NS
Catalog NumberOS917100-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
GS105055662960228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05055662960228]

Moist Heat or Steam Sterilization


[05055662960228]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-13