Quadra S femoral stems

GUDID 07630030802508

Quadra S Cementless Stem Standard size 8 Short Neck

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630030802508
• NIH Device Record Key: c073569b-e3b6-4625-9146-1951a89be69c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quadra S femoral stems
• Version Model Number: 01.12.08SN
• 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	07630030802508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093944

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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 S femoral stems]

• 07630030802942: Quadra S Cementless Stem Standard size 00 Short Neck
• 07630030802591: Quadra S Cementless Stem Lateralized size 7 Short Neck
• 07630030802584: Quadra S Cementless Stem Lateralized size 6 Short Neck
• 07630030802577: Quadra S Cementless Stem Lateralized size 5 Short Neck
• 07630030802560: Quadra S Cementless Stem Lateralized size 4 Short Neck
• 07630030802553: Quadra S Cementless Stem Lateralized size 3 Short Neck
• 07630030802546: Quadra S Cementless Stem Lateralized size 2 Short Neck
• 07630030802539: Quadra S Cementless Stem Lateralized size 1 Short Neck
• 07630030802522: Quadra S Cementless Stem Standard size 10 Short Neck
• 07630030802515: Quadra S Cementless Stem Standard size 9 Short Neck
• 07630030802508: Quadra S Cementless Stem Standard size 8 Short Neck
• 07630030802492: Quadra S Cementless Stem Standard size 7 Short Neck
• 07630030802485: Quadra S Cementless Stem Standard size 6 Short Neck
• 07630030802379: Quadra S Cementless Stem Standard size 5 Short Neck
• 07630030802294: Quadra S Cementless Stem Standard size 4 Short Neck
• 07630030802201: Quadra S Cementless Stem Standard size 3 Short Neck
• 07630030802119: Quadra S Cementless Stem Standard size 2 Short Neck
• 07630030802003: Quadra S Cementless Stem Standard size 1 Short Neck
• 07630030801990: Quadra S Cementless Stem Lateralized size 7
• 07630030801983: Quadra S Cementless Stem Lateralized size 6
• 07630030801976: Quadra S Cementless Stem Lateralized size 5
• 07630030801969: Quadra S Cementless Stem Lateralized size 4
• 07630030801952: Quadra S Cementless Stem Lateralized size 3
• 07630030801945: Quadra S Cementless Stem Lateralized size 2
• 07630030801938: Quadra S Cementless Stem Lateralized size 1
• 07630030801921: Quadra S Cementless Stem Standard size 10
• 07630030801914: Quadra S Cementless Stem Standard size 0 Short Neck
• 07630030801907: Quadra S Cementless Stem Standard size 9
• 07630030801891: Quadra S Cementless Stem Standard size 8
• 07630030801884: Quadra S Cementless Stem Standard size 7
• 07630030801877: Quadra S Cementless Stem Standard size 6
• 07630030801860: Quadra S Cementless Stem Standard size 5
• 07630030801853: Quadra S Cementless Stem Standard size 4
• 07630030801846: Quadra S Cementless Stem Standard size 3
• 07630030801839: Quadra S Cementless Stem Standard size 2
• 07630030801822: Quadra S Cementless Stem Standard size 1
• 07630030801815: Quadra S Cementless Stem Standard size 0