MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT,SMALL

GUDID 00848665032734

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00848665032734
NIH Device Record Keybef9b127-25bd-4493-9a31-3fc41b78a78c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMINIMALLY INVASIVE CALCANEAL PLATE, RIGHT,SMALL
Version Model Number3077-020
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

Phone3105339966
Emailregaffairs@aosortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665032734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665032734]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-19
Device Publish Date2020-06-16

Devices Manufactured by ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

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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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