Primary Device ID | 00843575120366 |
NIH Device Record Key | 7946e1cb-15b5-4a88-a268-8720b8dfea56 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kosmo Femoral Hip System |
Version Model Number | 8819040002 |
Catalog Number | 8819040002 |
Company DUNS | 081315444 |
Company Name | B-ONE ORTHO, CORP. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843575120366 [Primary] |
LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00843575120366]
Moist Heat or Steam Sterilization
[00843575120366]
Moist Heat or Steam Sterilization
[00843575120366]
Moist Heat or Steam Sterilization
[00843575120366]
Moist Heat or Steam Sterilization
[00843575120366]
Moist Heat or Steam Sterilization
[00843575120366]
Moist Heat or Steam Sterilization
[00843575120366]
Moist Heat or Steam Sterilization
[00843575120366]
Moist Heat or Steam Sterilization
[00843575120366]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-15 |
Device Publish Date | 2025-04-07 |
00843575111081 | FEMORAL BROACH TRAY |
00843575111050 | CURVED INSERTER |
00843575111043 | FEMORAL RESECTION GUIDE |
00843575111036 | NECK TRIAL COXA VARA, 40MM LENGTH |
00843575111029 | NECK TRIAL HIGH OFFSET, 43MM LENGTH |
00843575111012 | NECK TRIAL STANDARD OFFSET, 39MM LENGTH |
00843575110992 | BROACH, SIZE 9 |
00843575110978 | BROACH, SIZE 8 |
00843575110954 | BROACH, SIZE 7 |
00843575110930 | BROACH, SIZE 6 |
00843575110923 | BROACH, SIZE 5 |
00843575110916 | BROACH, SIZE 4 |
00843575110909 | BROACH, SIZE 3 |
00843575110893 | BROACH, SIZE 2 |
00843575110886 | BROACH, SIZE 1 |
00843575110879 | SCALLOP IMPACTOR |
00843575110725 | Coxa Vara Collared Hip Stem Size 9 |
00843575110701 | Coxa Vara Collared Hip Stem Size 8 |
00843575110688 | Coxa Vara Collared Hip Stem Size 7 |
00843575110664 | Coxa Vara Collared Hip Stem Size 6 |
00843575110657 | Coxa Vara Collared Hip Stem Size 5 |
00843575110640 | Coxa Vara Collared Hip Stem Size 4 |
00843575110633 | Coxa Vara Collared Hip Stem Size 3 |
00843575110626 | Coxa Vara Collared Hip Stem Size 2 |
00843575110619 | Coxa Vara Collared Hip Stem Size 1 |
00843575110596 | High Offset Collared Hip Stem Size 9 |
00843575110572 | High Offset Collared Hip Stem Size 8 |
00843575110558 | High Offset Collared Hip Stem Size 7 |
00843575110534 | High Offset Collared Hip Stem Size 6 |
00843575110527 | High Offset Collared Hip Stem Size 5 |
00843575110510 | High Offset Collared Hip Stem Size 4 |
00843575110503 | High Offset Collared Hip Stem Size 3 |
00843575110497 | High Offset Collared Hip Stem Size 2 |
00843575110480 | High Offset Collared Hip Stem Size 1 |
00843575110466 | Standard Collared Hip Stem Size 9 |
00843575110442 | Standard Collared Hip Stem Size 8 |
00843575110428 | Standard Collared Hip Stem Size 7 |
00843575110381 | Standard Collared Hip Stem Size 6 |
00843575110374 | Standard Collared Hip Stem Size 5 |
00843575110367 | Standard Collared Hip Stem Size 4 |
00843575110350 | Standard Collared Hip Stem Size 3 |
00843575110343 | Standard Collared Hip Stem Size 2 |
00843575110336 | Standard Collared Hip Stem Size 1 |
00843575124623 | NECK TRIAL, COXA VARA COLLARED, 125°, 40MM |
00843575124616 | NECK TRIAL, HIGH OFFSET COLLARED, 135°, 43MM |
00843575124609 | NECK TRIAL, STANDARD OFFSET COLLARED, 135°, 39MM |
00843575124340 | Cement Restrictor Tray |
00843575124333 | Kosmo Broach Tray |
00843575121066 | Cement Restrictor, Size 7 |
00843575121059 | Cement Restrictor, Size 6 |