Quadra H femoral stems

GUDID 07630030802010

QUADRA H Cementless Stem Standard size 0

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630030802010
• NIH Device Record Key: b1544d9b-5cfc-4204-b7f5-c6d5eceada1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quadra H femoral stems
• Version Model Number: 01.12.020
• 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	07630030802010 [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 H femoral stems]

• 07630030802935: Quadra H Cementless Stem Standard size 00 Short Neck
• 07630030802775: Quadra H Cementless Stem Lateralized size 7 Short Neck
• 07630030802768: Quadra H Cementless Stem Lateralized size 6 Short Neck
• 07630030802751: Quadra H Cementless Stem Lateralized size 5 Short Neck
• 07630030802744: Quadra H Cementless Stem Lateralized size 4 Short Neck
• 07630030802737: Quadra H Cementless Stem Lateralized size 3 Short Neck
• 07630030802720: Quadra H Cementless Stem Lateralized size 2 Short Neck
• 07630030802713: Quadra H Cementless Stem Lateralized size 1 Short Neck
• 07630030802706: Quadra H Cementless Stem Standard size 10 Short Neck
• 07630030802690: Quadra H Cementless Stem Standard size 9 Short Neck
• 07630030802683: Quadra H Cementless Stem Standard size 8 Short Neck
• 07630030802676: Quadra H Cementless Stem Standard size 7 Short Neck
• 07630030802669: Quadra H Cementless Stem Standard size 6 Short Neck
• 07630030802652: Quadra H Cementless Stem Standard size 5 Short Neck
• 07630030802645: Quadra H Cementless Stem Standard size 4 Short Neck
• 07630030802638: Quadra H Cementless Stem Standard size 3 Short Neck
• 07630030802621: Quadra H Cementless Stem Standard size 2 Short Neck
• 07630030802614: Quadra H Cementless Stem Standard size 1 Short Neck
• 07630030802607: Quadra H Cementless Stem Standard size 0 Short Neck
• 07630030802195: Quadra H Cementless Stem Lateralized size 7
• 07630030802188: Quadra H Cementless Stem Lateralized size 6
• 07630030802171: Quadra H Cementless Stem Lateralized size 5
• 07630030802164: Quadra H Cementless Stem Lateralized size 4
• 07630030802157: Quadra H Cementless Stem Lateralized size 3
• 07630030802140: Quadra H Cementless Stem Lateralized size 2
• 07630030802133: Quadra H Cementless Stem Lateralized size 1
• 07630030802126: QUADRA H Cementless Stem Standard size 10
• 07630030802102: QUADRA H Cementless Stem Standard size 9
• 07630030802096: QUADRA H Cementless Stem Standard size 8
• 07630030802089: QUADRA H Cementless Stem Standard size 7
• 07630030802072: QUADRA H Cementless Stem Standard size 6
• 07630030802065: QUADRA H Cementless Stem Standard size 5
• 07630030802058: QUADRA H Cementless Stem Standard size 4
• 07630030802041: QUADRA H Cementless Stem Standard size 3
• 07630030802034: QUADRA H Cementless Stem Standard size 2
• 07630030802027: QUADRA H Cementless Stem Standard size 1
• 07630030802010: QUADRA H Cementless Stem Standard size 0