CORTICAL LOCKING SCREW 3.5mm x 8mm

GUDID 00848665007541

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00848665007541
NIH Device Record Key4e608642-3c5d-430d-9cbc-dae733c95edb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCORTICAL LOCKING SCREW 3.5mm x 8mm
Version Model Number8012-080
Company DUNS117858154
Company NameADVANCED ORTHOPEDIC SOLUTIONS INC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665007541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665007541]

Moist Heat or Steam Sterilization


[00848665007541]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-22

On-Brand Devices [CORTICAL LOCKING SCREW 3.5mm x 8mm]

008486650077878014-080
008486650075418012-080

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.