Kosmo Femoral Hip System 8819000015

GUDID 00843575111036

NECK TRIAL COXA VARA, 40MM LENGTH

B-ONE ORTHO, CORP.

Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial
Primary Device ID00843575111036
NIH Device Record Key374d71d7-0845-405d-bc75-40ba71ab61b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameKosmo Femoral Hip System
Version Model Number8819000015
Catalog Number8819000015
Company DUNS081315444
Company NameB-ONE ORTHO, CORP.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100843575111036 [Primary]

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


[00843575111036]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-08
Device Publish Date2021-06-30

On-Brand Devices [Kosmo Femoral Hip System]

00843575111081FEMORAL BROACH TRAY
00843575111050CURVED INSERTER
00843575111043FEMORAL RESECTION GUIDE
00843575111036NECK TRIAL COXA VARA, 40MM LENGTH
00843575111029NECK TRIAL HIGH OFFSET, 43MM LENGTH
00843575111012NECK TRIAL STANDARD OFFSET, 39MM LENGTH
00843575110992BROACH, SIZE 9
00843575110978BROACH, SIZE 8
00843575110954BROACH, SIZE 7
00843575110930BROACH, SIZE 6
00843575110923BROACH, SIZE 5
00843575110916BROACH, SIZE 4
00843575110909BROACH, SIZE 3
00843575110893BROACH, SIZE 2
00843575110886BROACH, SIZE 1
00843575110879SCALLOP IMPACTOR
00843575110725Coxa Vara Collared Hip Stem Size 9
00843575110701Coxa Vara Collared Hip Stem Size 8
00843575110688Coxa Vara Collared Hip Stem Size 7
00843575110664Coxa Vara Collared Hip Stem Size 6
00843575110657Coxa Vara Collared Hip Stem Size 5
00843575110640Coxa Vara Collared Hip Stem Size 4
00843575110633Coxa Vara Collared Hip Stem Size 3
00843575110626Coxa Vara Collared Hip Stem Size 2
00843575110619Coxa Vara Collared Hip Stem Size 1
00843575110596High Offset Collared Hip Stem Size 9
00843575110572High Offset Collared Hip Stem Size 8
00843575110558High Offset Collared Hip Stem Size 7
00843575110534High Offset Collared Hip Stem Size 6
00843575110527High Offset Collared Hip Stem Size 5
00843575110510High Offset Collared Hip Stem Size 4
00843575110503High Offset Collared Hip Stem Size 3
00843575110497High Offset Collared Hip Stem Size 2
00843575110480High Offset Collared Hip Stem Size 1
00843575110466Standard Collared Hip Stem Size 9
00843575110442Standard Collared Hip Stem Size 8
00843575110428Standard Collared Hip Stem Size 7
00843575110381Standard Collared Hip Stem Size 6
00843575110374Standard Collared Hip Stem Size 5
00843575110367Standard Collared Hip Stem Size 4
00843575110350Standard Collared Hip Stem Size 3
00843575110343Standard Collared Hip Stem Size 2
00843575110336Standard Collared Hip Stem Size 1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.