Mpact 3D Metal

GUDID 07630030889134

Augments 70/72 15mm

Medacta International SA

Metallic acetabulum prosthesis

• Primary Device ID: 07630030889134
• NIH Device Record Key: 680b42de-2b71-4931-98f9-da6c0a8d0bd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpact 3D Metal
• Version Model Number: 01.38.116
• 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	07630030889134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171966

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: 2021-11-02
• Device Publish Date: 2021-10-25

On-Brand Devices [Mpact 3D Metal]

• 07630040708029: Acetabular shell Ø72 Multi-hole
• 07630040708012: Acetabular shell Ø70 Multi-hole
• 07630040708005: Acetabular shell Ø68 Multi-hole
• 07630040707992: Acetabular shell Ø66 Multi-hole
• 07630040707985: Acetabular shell Ø64 Multi-hole
• 07630040707978: Acetabular shell Ø62 Multi-hole
• 07630040707961: Acetabular shell Ø60 Multi-hole
• 07630040707954: Acetabular shell Ø58 Multi-hole
• 07630040707947: Acetabular shell Ø56 Multi-hole
• 07630040707930: Acetabular shell Ø54 Multi-hole
• 07630040707923: Acetabular shell Ø52 Multi-hole
• 07630040707916: Acetabular shell Ø50 Multi-hole
• 07630040707909: Acetabular shell Ø48 Multi-hole
• 07630030889158: Augments 70/72 30mm
• 07630030889141: Augments 70/72 20mm
• 07630030889134: Augments 70/72 15mm
• 07630030889127: Augments 66/68 30mm
• 07630030889110: Augments 66/68 20mm
• 07630030889103: Augments 66/68 15mm
• 07630030889097: Augments 62/64 30mm
• 07630030889080: Augments 62/64 20mm
• 07630030889073: Augments 62/64 15mm
• 07630030889066: Augments 58/60 30mm
• 07630030889059: Augments 58/60 20mm
• 07630030889042: Augments 58/60 15mm
• 07630030889035: Augments 54/56 30mm
• 07630030889028: Augments 54/56 20mm
• 07630030889011: Augments 54/56 15mm
• 07630030889004: Augments 50/52 30mm
• 07630030888991: Augments 50/52 20mm
• 07630030888984: Augments 50/52 15mm
• 07630030885471: Acetabular shell Ø46 Multi-hole
• 07630030812668: Acetabular shell Ø66 Two-hole
• 07630030812651: Acetabular shell Ø64 Two-hole
• 07630030812644: Acetabular shell Ø62 Two-hole
• 07630030812637: Acetabular shell Ø60 Two-hole
• 07630030812620: Acetabular shell Ø58 Two-hole
• 07630030812613: Acetabular shell Ø56 Two-hole
• 07630030812606: Acetabular shell Ø54 Two-hole
• 07630030812590: Acetabular shell Ø52 Two-hole
• 07630030812583: Acetabular shell Ø50 Two-hole
• 07630030812576: Acetabular shell Ø48 Two-hole
• 07630030812569: Acetabular shell Ø46 Two-hole