PERIMETER CALCANEAL PLATE LEFT, EXTRA SMALL

GUDID 00848665036183

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00848665036183
NIH Device Record Key236df2ef-f678-488a-8f8b-f9a85cb85538
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERIMETER CALCANEAL PLATE LEFT, EXTRA SMALL
Version Model Number3078-010
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
GS100848665036183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665036183]

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.

00848665032703 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, SMALL2024-02-19
00848665032710 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, MEDIUM2024-02-19
00848665032727 - MINIMALLY INVASIVE CALCANEAL PLATE, LEFT, LARGE2024-02-19
00848665032734 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT,SMALL2024-02-19
00848665032741 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, MEDIUM2024-02-19
00848665032758 - MINIMALLY INVASIVE CALCANEAL PLATE, RIGHT, LARGE2024-02-19
00848665034066 - BENDING TEMPLATE,MINIMALLY INVASIVE CALCANEAL PLATE, EXTRA SMALL2024-02-19
00848665035988 - VARIABLE ANGLE LOCKING SCREW, 3.5mm x 95mm 2024-02-19

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