Mpres Neck Preserving Stem

GUDID 07630345713513

Mpres Stem LAT #5

Medacta International SA

Press-fit hip femur prosthesis, one-piece

• Primary Device ID: 07630345713513
• NIH Device Record Key: b657e02e-86c2-498b-b41a-fd90d106433f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpres Neck Preserving Stem
• Version Model Number: 01.37.025
• 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	07630345713513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210263

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: 2021-10-04
• Device Publish Date: 2021-09-24

On-Brand Devices [Mpres Neck Preserving Stem]

• 07630345713605: Mpres Stem LAT #14
• 07630345713599: Mpres Stem LAT #13
• 07630345713582: Mpres Stem LAT #12
• 07630345713575: Mpres Stem LAT #11
• 07630345713568: Mpres Stem LAT #10
• 07630345713551: Mpres Stem LAT #9
• 07630345713544: Mpres Stem LAT #8
• 07630345713537: Mpres Stem LAT #7
• 07630345713520: Mpres Stem LAT #6
• 07630345713513: Mpres Stem LAT #5
• 07630345713506: Mpres Stem LAT #4
• 07630345713490: Mpres Stem LAT #3
• 07630345713469: Mpres Stem STD #14
• 07630345713452: Mpres Stem STD #13
• 07630345713445: Mpres Stem STD #12
• 07630345713438: Mpres Stem STD #11
• 07630345713421: Mpres Stem STD #10
• 07630345713414: Mpres Stem STD #9
• 07630345713407: Mpres Stem STD #8
• 07630345713391: Mpres Stem STD #7
• 07630345713384: Mpres Stem STD #6
• 07630345713377: Mpres Stem STD #5
• 07630345713360: Mpres Stem STD #4
• 07630345713353: Mpres Stem STD #3