AP Connection Bolt 1290-100

GUDID 00848665034219

ADVANCED ORTHOPEDIC SOLUTIONS INC

Orthopaedic fixation implant alignment tool
Primary Device ID00848665034219
NIH Device Record Key24894a37-19aa-4036-ae9c-61257d7a097c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAP Connection Bolt
Version Model Number1290-100
Catalog Number1290-100
Company DUNS117858154
Company NameADVANCED ORTHOPEDIC 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 Usefalse
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
Emailregaffairs@aosortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665034219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848665034219]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-24
Device Publish Date2020-02-14

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

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00848665000658 - AOS Drill, AO Style, 2.9mm x 100mm2020-06-08
00848665001235 - AOS CANCELLOUS TAP 3.5mm2020-06-08
00848665027624 - SUPRAPATELLAR TIBIAL ENTRY SHEATH2020-06-08
00848665028041 - T10 Screwdriver, Short2020-06-08
00848665028096 - 3.5mm Calibrated Drill2020-06-08
00848665028119 - AOS 2.6mm Solid Reamer2020-06-08
00848665028782 - T10 Screwdriver, Solid2020-06-08

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