Mpact 3D Metal Augments II

GUDID 07630542723841

Double Augment Technique Screw

Medacta International SA

Acetabular augmentation implant

• Primary Device ID: 07630542723841
• NIH Device Record Key: 6df71760-4ad5-4163-acee-d6e9fa5ba949
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpact 3D Metal Augments II
• Version Model Number: 01.38.50010
• 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: true
• 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	07630542723841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242232

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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: 2025-05-12
• Device Publish Date: 2025-05-02

On-Brand Devices [Mpact 3D Metal Augments II]

• 07630542700477: Augments II Ø46 15mm
• 07630542700460: Augments II Ø46 10mm
• 07630542700934: Augments II Ø80 20mm
• 07630542700927: Augments II Ø80 15mm
• 07630542700910: Augments II Ø80 10mm
• 07630542700903: Augments II Ø74 20mm
• 07630542700897: Augments II Ø74 15mm
• 07630542700880: Augments II Ø74 10mm
• 07630542700873: Augments II Ø72 20mm
• 07630542700866: Augments II Ø72 15mm
• 07630542700859: Augments II Ø72 10mm
• 07630542700842: Augments II Ø70 20mm
• 07630542700835: Augments II Ø70 15mm
• 07630542700828: Augments II Ø70 10mm
• 07630542700811: Augments II Ø68 20mm
• 07630542700804: Augments II Ø68 15mm
• 07630542700798: Augments II Ø68 10mm
• 07630542700781: Augments II Ø66 20mm
• 07630542700774: Augments II Ø66 15mm
• 07630542700767: Augments II Ø66 10mm
• 07630542700750: Augments II Ø64 20mm
• 07630542700743: Augments II Ø64 15mm
• 07630542700736: Augments II Ø64 10mm
• 07630542700729: Augments II Ø62 20mm
• 07630542700712: Augments II Ø62 15mm
• 07630542700705: Augments II Ø62 10mm
• 07630542700699: Augments II Ø60 20mm
• 07630542700682: Augments II Ø60 15mm
• 07630542700675: Augments II Ø60 10mm
• 07630542700668: Augments II Ø58 20mm
• 07630542700651: Augments II Ø58 15mm
• 07630542700644: Augments II Ø58 10mm
• 07630542700637: Augments II Ø56 20mm
• 07630542700620: Augments II Ø56 15mm
• 07630542700613: Augments II Ø56 10mm
• 07630542700606: Augments II Ø54 20mm
• 07630542700590: Augments II Ø54 15mm
• 07630542700583: Augments II Ø54 10mm
• 07630542700576: Augments II Ø52 20mm
• 07630542700569: Augments II Ø52 15mm
• 07630542700552: Augments II Ø52 10mm
• 07630542700545: Augments II Ø50 20mm
• 07630542700538: Augments II Ø50 15mm
• 07630542700521: Augments II Ø50 10mm
• 07630542700514: Augments II Ø48 20mm
• 07630542700507: Augments II Ø48 15mm
• 07630542700491: Augments II Ø48 10mm
• 07630542700484: Augments II Ø46 20mm
• 07630542723841: Double Augment Technique Screw