Kosmo Femoral Hip System 8819000003

GUDID 00843575110909

BROACH, SIZE 3

B-ONE ORTHO, CORP.

Orthopaedic broach

• Primary Device ID: 00843575110909
• NIH Device Record Key: bed274a0-a5d3-475d-afc4-a25a3ce39d46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kosmo Femoral Hip System
• Version Model Number: 8819000003
• Catalog Number: 8819000003
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00843575110909 [Primary]

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

[00843575110909]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [Kosmo Femoral Hip System]

• 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