AOS SCREW SPACER/COMPRESSION BOLT

GUDID 00848665012576

ADVANCED ORTHOPEDIC SOLUTIONS INC

Bone nail end-cap, sterile
Primary Device ID00848665012576
NIH Device Record Key75fdcfb5-957a-4f12-b354-46983a46eb15
Commercial Distribution Discontinuation2017-06-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAOS SCREW SPACER/COMPRESSION BOLT
Version Model NumberS1326
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848665012576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-22
Device Publish Date2015-12-18

Devices Manufactured by ADVANCED ORTHOPEDIC SOLUTIONS INC

00848665027679 - COUNTERSINK2020-06-23
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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