Mpact Acetabular System

GUDID 07630030811289

Hooded PE HC Liner Ø 22 / D

Medacta International SA

Non-constrained polyethylene acetabular liner

• Primary Device ID: 07630030811289
• NIH Device Record Key: 1918c1c5-fdc3-4863-950b-1d1de3e2b10b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mpact Acetabular System
• Version Model Number: 01.32.2241HCAT
• 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	07630030811289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103721

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-18

On-Brand Devices [Mpact Acetabular System]

• 07630030860911: Mpact Shell screw plug
• 07630030812477: Cancellous bone screw, flat head Ø 6,5 L 70
• 07630030812460: Cancellous bone screw, flat head Ø 6,5 L 65
• 07630030812453: Cancellous bone screw, flat head Ø 6,5 L 60
• 07630030812446: Cancellous bone screw, flat head Ø 6,5 L 55
• 07630030812439: Cancellous bone screw, flat head Ø 6,5 L 50
• 07630030812422: Cancellous bone screw flat head Ø 6,5 L45
• 07630030812415: Cancellous bone screw flat head Ø 6,5 L40
• 07630030812408: Cancellous bone screw flat head Ø 6,5 L35
• 07630030812392: Cancellous bone screw flat head Ø 6,5 L30
• 07630030812385: Cancellous bone screw flat head Ø 6,5 L25
• 07630030812378: Cancellous bone screw flat head Ø 6,5 L20
• 07630030812361: Cancellous bone screw flat head Ø 6,5 L15
• 07630030812316: Flat PE HC liner Ø 40 / K
• 07630030812309: Flat PE HC liner Ø 40 / J
• 07630030812293: Cortical bone screw flat head Ø 4 L55
• 07630030812286: Flat PE HC liner Ø 40 / G
• 07630030812279: Cortical bone screw flat head Ø 4 L50
• 07630030812262: Flat PE HC liner Ø 40 / F
• 07630030812255: Cortical bone screw flat head Ø 4 L45
• 07630030812248: Cortical bone screw flat head Ø 4 L40
• 07630030812231: Cortical bone screw flat head Ø 4 L35
• 07630030812224: Cortical bone screw flat head Ø 4 L30
• 07630030812217: Cortical bone screw flat head Ø 4 L25
• 07630030812194: Flat PE HC liner Ø 36 / K
• 07630030812187: Hooded PE HC liner Ø 36 / K
• 07630030812170: Flat PE HC liner Ø 36 / J
• 07630030812163: Hooded PE HC liner Ø 36 / J
• 07630030812156: Flat PE HC liner Ø 36 / G
• 07630030812149: Hooded PE HC Liner Ø 36 / G
• 07630030812132: Flat PE HC liner Ø 36 / F
• 07630030812125: Hooded PE HC Liner Ø 36 / F
• 07630030812118: Flat PE HC liner Ø 36 / E
• 07630030812101: Hooded PE HC Liner Ø 36 / E
• 07630030812088: Flat PE liner Ø 32 / K
• 07630030812071: Flat PE HC liner Ø 32 / K
• 07630030812064: Hooded PE HC liner Ø 32 / K
• 07630030812057: Hooded PE liner Ø 32 / K
• 07630030812040: Flat PE liner Ø 32 / J
• 07630030812033: Flat PE HC liner Ø 32 / J
• 07630030812026: Hooded PE HC liner Ø 32 / J
• 07630030812019: Hooded PE liner Ø 32 / J
• 07630030812002: Flat PE liner Ø 32 / G
• 07630030811999: Flat PE HC liner Ø 32 /G
• 07630030811982: Hooded PE HC Liner Ø 32 / G
• 07630030811975: Hooded PE Liner Ø 32 / G
• 07630030811968: Flat PE liner Ø 32 / F
• 07630030811951: Flat PE HC liner Ø 32 / F
• 07630030811944: Hooded PE HC Liner Ø 32 / F
• 07630030811937: Hooded PE Liner Ø 32 / F