Quadra P femoral stems

GUDID 07630971243491

Quadra-P Short Neck STD stem #8

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630971243491
• NIH Device Record Key: b9bc51a4-65e0-414d-9baa-874dae073d5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quadra P femoral stems
• Version Model Number: 01.12.258
• 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	07630971243491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192827

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-17
• Device Publish Date: 2020-03-09

On-Brand Devices [Quadra P femoral stems]

• 07630971243620: Quadra-P Short Neck LAT stem #10
• 07630971243613: Quadra-P Short Neck LAT stem #9
• 07630971243606: Quadra-P Short Neck LAT stem #8
• 07630971243590: Quadra-P Short Neck LAT stem #7
• 07630971243583: Quadra-P Short Neck LAT stem #6
• 07630971243576: Quadra-P Short Neck LAT stem #5
• 07630971243569: Quadra-P Short Neck LAT stem #4
• 07630971243552: Quadra-P Short Neck LAT stem #3
• 07630971243545: Quadra-P Short Neck LAT stem #2
• 07630971243538: Quadra-P Short Neck LAT stem #1
• 07630971243521: Quadra-P Short Neck LAT stem #0
• 07630971243514: Quadra-P Short Neck STD stem #10
• 07630971243507: Quadra-P Short Neck STD stem #9
• 07630971243491: Quadra-P Short Neck STD stem #8
• 07630971243484: Quadra-P Short Neck STD stem #7
• 07630971243477: Quadra-P Short Neck STD stem #6
• 07630971243460: Quadra-P Short Neck STD stem #5
• 07630971243453: Quadra-P Short Neck STD stem #4
• 07630971243446: Quadra-P Short Neck STD stem #3
• 07630971243439: Quadra-P Short Neck STD stem #2
• 07630971243422: Quadra-P Short Neck STD stem #1
• 07630971243415: Quadra-P Short Neck STD stem #0
• 07630040732246: Quadra-P Cemented LAT stem #8
• 07630040732239: Quadra-P Cemented LAT stem #7
• 07630040732222: Quadra-P Cemented LAT stem #6
• 07630040732215: Quadra-P Cemented LAT stem #5
• 07630040732208: Quadra-P Cemented LAT stem #4
• 07630040732192: Quadra-P Cemented LAT stem #3
• 07630040732185: Quadra-P Cemented LAT stem #2
• 07630040732178: Quadra-P Cemented LAT stem #1
• 07630040732161: Quadra-P Cemented LAT stem #0
• 07630040732154: Quadra-P Cemented STD stem #8
• 07630040732147: Quadra-P Cemented STD stem #7
• 07630040732130: Quadra-P Cemented STD stem #6
• 07630040732123: Quadra-P Cemented STD stem #5
• 07630040732116: Quadra-P Cemented STD stem #4
• 07630040732109: Quadra-P Cemented STD stem #3
• 07630040732093: Quadra-P Cemented STD stem #2
• 07630040732086: Quadra-P Cemented STD stem #1
• 07630040732079: Quadra-P Cemented STD stem #0
• 07630040732055: Quadra-P Collared LAT stem #10
• 07630040732048: Quadra-P Collared LAT stem #9
• 07630040732031: Quadra-P Collared LAT stem #8
• 07630040732024: Quadra-P Collared LAT stem #7
• 07630040732017: Quadra-P Collared LAT stem #6
• 07630040732000: Quadra-P Collared LAT stem #5
• 07630040731997: Quadra-P Collared LAT stem #4
• 07630040731980: Quadra-P Collared LAT stem #3
• 07630040731973: Quadra-P Collared LAT stem #2
• 07630040731966: Quadra-P Collared LAT stem #1