Quadra C femoral stems

GUDID 07630030802324

Quadra C Cemented Lateralized stem size 3

Medacta International SA

Uncoated hip femur prosthesis, one-piece

• Primary Device ID: 07630030802324
• NIH Device Record Key: 72f4e07e-29c8-447e-a3c3-ffddfc74e790
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quadra C femoral stems
• Version Model Number: 01.12.053
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07630030802324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083558

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-18

On-Brand Devices [Quadra C femoral stems]

• 07630030802928: Quadra C Cemented Stem Lateralized size 7 Short Neck
• 07630030802911: Quadra C Cemented Stem Lateralized size 6 Short Neck
• 07630030802904: Quadra C Cemented Stem Lateralized size 5 Short Neck
• 07630030802898: Quadra C Cemented Stem Lateralized size 4 Short Neck
• 07630030802881: Quadra C Cemented Stem Lateralized size 3 Short Neck
• 07630030802874: Quadra C Cemented Stem Lateralized size 2 Short Neck
• 07630030802867: Quadra C Cemented Stem Lateralized size 1 Short Neck
• 07630030802850: Quadra C Cemented Stem Standard size 7 Short Neck
• 07630030802843: Quadra C Cemented Stem Standard size 6 Short Neck
• 07630030802836: Quadra C Cemented Stem Standard size 5 Short Neck
• 07630030802829: Quadra C Cemented Stem Standard size 4 Short Neck
• 07630030802812: Quadra C Cemented Stem Standard size 3 Short Neck
• 07630030802805: Quadra C Cemented Stem Standard size 2 Short Neck
• 07630030802799: Quadra C Cemented Stem Standard size 1 Short Neck
• 07630030802782: Quadra C Cemented Stem Standard size 0 Short Neck
• 07630030802362: Quadra C Cemented Lateralized stem size 7
• 07630030802355: Quadra C Cemented Lateralized stem size 6
• 07630030802348: Quadra C Cemented Lateralized stem size 5
• 07630030802331: Quadra C Cemented Lateralized stem size 4
• 07630030802324: Quadra C Cemented Lateralized stem size 3
• 07630030802317: Quadra C Cemented Lateralized stem size 2
• 07630030802300: Quadra C Cemented Lateralized stem size 1
• 07630030802287: Quadra C Cemented Standard stem size 7
• 07630030802270: Quadra C Cemented Standard stem size 6
• 07630030802263: Quadra C Cemented Standard stem size 5
• 07630030802256: Quadra C Cemented Standard stem size 4
• 07630030802249: Quadra C Cemented Standard stem size 3
• 07630030802232: Quadra C Cemented Standard stem size 2
• 07630030802225: Quadra C Cemented Standard stem size 1
• 07630030802218: Quadra C Cemented Standard stem size 0