Mpact 3D Metal Acetabular System

GUDID 07630040723350

Compression Polyaxial Locking Screw Ø6.5 – L65 mm

Medacta International SA

Acetabular shell

• Primary Device ID: 07630040723350
• NIH Device Record Key: 7277c86a-5aa7-404b-a966-a9348c4c11c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpact 3D Metal Acetabular System
• Version Model Number: 01.38.265
• 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	07630040723350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202568

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: 2021-12-31
• Device Publish Date: 2021-12-23

On-Brand Devices [Mpact 3D Metal Acetabular System]

• 07630971212626: Acetabular shell Ø60 Multi-hole Thin
• 07630971212619: Acetabular shell Ø58 Multi-hole Thin
• 07630971212602: Acetabular shell Ø56 Multi-hole Thin
• 07630971212596: Acetabular shell Ø54 Multi-hole Thin
• 07630971212589: Acetabular shell Ø52 Multi-hole Thin
• 07630971212572: Acetabular shell Ø50 Multi-hole Thin
• 07630971212565: Acetabular shell Ø48 Multi-hole Thin
• 07630040723367: Compression Polyaxial Locking Screw Ø6.5 – L70 mm
• 07630040723350: Compression Polyaxial Locking Screw Ø6.5 – L65 mm
• 07630040723343: Compression Polyaxial Locking Screw Ø6.5 – L60 mm
• 07630040723336: Compression Polyaxial Locking Screw Ø6.5 – L55 mm
• 07630040723329: Compression Polyaxial Locking Screw Ø6.5 – L50 mm
• 07630040723312: Compression Polyaxial Locking Screw Ø6.5 – L45 mm
• 07630040723305: Compression Polyaxial Locking Screw Ø6.5 – L40 mm
• 07630040723299: Compression Polyaxial Locking Screw Ø6.5 – L35 mm
• 07630040723282: Compression Polyaxial Locking Screw Ø6.5 – L30 mm
• 07630040723275: Compression Polyaxial Locking Screw Ø6.5 – L25 mm
• 07630040723268: Compression Polyaxial Locking Screw Ø6.5 – L20 mm