Quadra R femoral stems

GUDID 07630030802461

Quadra R Cementless Stem size 8

Medacta International SA

Revision coated hip femur prosthesis

• Primary Device ID: 07630030802461
• NIH Device Record Key: ee4c7f62-0b10-42b2-845e-5a07859161ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quadra R femoral stems
• Version Model Number: 01.12.068
• 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	07630030802461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082792

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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 R femoral stems]

• 07630030802478: Quadra R Cementless Stem size 9
• 07630030802461: Quadra R Cementless Stem size 8
• 07630030802454: Quadra R Cementless Stem size 7
• 07630030802447: Quadra R Cementless Stem size 6
• 07630030802430: Quadra R Cementless Stem size 5
• 07630030802423: Quadra R Cementless Stem size 4
• 07630030802416: Quadra R Cementless Stem size 3
• 07630030802409: Quadra R Cementless Stem size 2
• 07630030802393: Quadra R Cementless Stem size 1
• 07630030802386: Quadra R Cementless Stem size 0