Evolution Revision CCK System E5004105

GUDID M684E50041051

Microport Orthopedics Inc.

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• Primary Device ID: M684E50041051
• NIH Device Record Key: 7c81e0fc-8584-48d4-97fd-94b142653f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolution Revision CCK System
• Version Model Number: E5004105
• Catalog Number: E5004105
• Company DUNS: 079118736
• Company Name: Microport Orthopedics Inc.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M684E50041051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171389

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

[M684E50041051]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-05-03
• Device Publish Date: 2018-05-16

On-Brand Devices [Evolution Revision CCK System]

• M684EFCCN8RR1: EFCCN8RR
• M684EFCCN8RL1: EFCCN8RL
• M684EFCCN7RR1: EFCCN7RR
• M684EFCCN7RL1: EFCCN7RL
• M684EFCCN6RR1: EFCCN6RR
• M684EFCCN6RL1: EFCCN6RL
• M684EFCCN5RR1: EFCCN5RR
• M684EFCCN5RL1: EFCCN5RL
• M684EFCCN4RR1: EFCCN4RR
• M684EFCCN4RL1: EFCCN4RL
• M684EFCCN3RR1: EFCCN3RR
• M684EFCCN3RL1: EFCCN3RL
• M684EFCCN2RR1: EFCCN2RR
• M684EFCCN2RL1: EFCCN2RL
• M684EFCCN1RR1: EFCCN1RR
• M684EFCCN1RL1: EFCCN1RL
• M684ESRF08251: ESRF0825
• M684ESRF04251: ESRF0425
• M684E50041101: E5004110
• M684E50041051: E5004105
• M684E50031121: E5003112
• M684E50031081: E5003108
• M684E50031041: E5003104
• M684E50010111: E5001011
• M684E12001171: E1200117
• M684E11010061: E1101006