VARIABLE ANGLE LOCKING SCREW, 3.5mm x 95mm

GUDID 00848665035988

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00848665035988
NIH Device Record Key8d193f6e-fb37-425c-8f2b-44ccafd052e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameVARIABLE ANGLE LOCKING SCREW, 3.5mm x 95mm
Version Model Number8088-095
Company DUNS117858154
Company NameADVANCED ORTHOPAEDIC 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone310533-9966
Emailregaffairs@aosortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665035988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665035988]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-02-19
Device Publish Date2020-05-27

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