STRAIGHT PLATE, 19-HOLE

GUDID 00848665029079

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00848665029079
NIH Device Record Key772ab5cb-881a-46e3-ada6-68891fbde09a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRAIGHT PLATE, 19-HOLE
Version Model Number3061-019
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

Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com
Phone310-533-9966
EmailATI_Regulatory@arthrex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665029079 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


[00848665029079]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-13
Device Publish Date2024-11-05

Devices Manufactured by ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

00848665028980 - SEMI-TUBULAR PLATE, 13-HOLE2024-11-13
00848665029000 - SEMI-TUBULAR PLATE, 15-HOLE2024-11-13
00848665029017 - SEMI-TUBULAR PLATE, 17-HOLE2024-11-13
00848665029024 - SEMI-TUBULAR PLATE, 19-HOLE2024-11-13
00848665029031 - SEMI-TUBULAR PLATE, 21-HOLE2024-11-13
00848665029048 - STRAIGHT PLATE, 13-HOLE2024-11-13
00848665029055 - STRAIGHT PLATE, 15-HOLE2024-11-13
00848665029062 - STRAIGHT PLATE, 17-HOLE2024-11-13

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