PROXIMAL LATERAL TIBIA PLATE, RIGHT, 11 HOLE

GUDID 00848665039436

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00848665039436
NIH Device Record Key4016cff2-4097-4215-af0e-2d06cc4d1f85
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROXIMAL LATERAL TIBIA PLATE, RIGHT, 11 HOLE
Version Model Number3082-111
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
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
GS100848665039436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

[00848665039436]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-18
Device Publish Date2022-02-10

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