EVOLUTION E1400015

GUDID M684E14000151

Microport Orthopedics Inc.

Joint prosthesis implantation kit, reusable

• Primary Device ID: M684E14000151
• NIH Device Record Key: bf2d8fbe-8d20-4251-9835-252343e22b6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLUTION
• Version Model Number: E1400015
• Catalog Number: E1400015
• Company DUNS: 079118736
• Company Name: Microport Orthopedics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M684E14000151 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[M684E14000151]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-03
• Device Publish Date: 2019-03-26

On-Brand Devices [EVOLUTION]

• M684E14041081: E1404108
• M684E14041071: E1404107
• M684E14041061: E1404106
• M684E14041051: E1404105
• M684E14041041: E1404104
• M684E14041031: E1404103
• M684E14041021: E1404102
• M684E140002R1: E140002R
• M684E140002L1: E140002L
• M684E140001R1: E140001R
• M684E140001L1: E140001L
• M684E14000151: E1400015
• M684E14000121: E1400012
• M684E14000061: E1400006
• M684E14000051: E1400005
• M684E14000031: E1400003
• M684E14000021: E1400002
• M684E14000011: E1400001
• M684E243118F1: E243118F
• M684ETPSB2PR1: ETPSB2PR
• ETPKN8SR: EVOLUTION® MP TIB KEELED NONPOR SIZE 8 STANDARD RIGHT
• ETPKN8SL: EVOLUTION® MP TIB KEELED NONPOR SIZE 8 STANDARD LEFT
• ETPKN8PR: EVOLUTION® MP TIB KEELED NONPOR SIZE 8+ RIGHT
• ETPKN8PL: EVOLUTION® MP TIB KEELED NONPOR SIZE 8+ LEFT
• ETPKN7SR: EVOLUTION® MP TIB KEELED NONPOR SIZE 7 STANDARD RIGHT
• ETPKN7SL: EVOLUTION® MP TIB KEELED NONPOR SIZE 7 STANDARD LEFT
• ETPKN6SR: EVOLUTION® MP TIB KEELED NONPOR SIZE 6 STANDARD RIGHT
• ETPKN6SL: EVOLUTION® MP TIB KEELED NONPOR SIZE 6 STANDARD LEFT
• ETPKN6PR: EVOLUTION® MP TIB KEELED NONPOR SIZE 6+ RIGHT
• ETPKN6PL: EVOLUTION® MP TIB KEELED NONPOR SIZE 6+ LEFT
• ETPKN5SR: EVOLUTION® MP TIB KEELED NONPOR SIZE 5 STANDARD RIGHT
• ETPKN5SL: EVOLUTION® MP TIB KEELED NONPOR SIZE 5 STANDARD LEFT
• ETPKN4SR: EVOLUTION® MP TIB KEELED NONPOR SIZE 4 STANDARD RIGHT
• ETPKN4SL: EVOLUTION® MP TIB KEELED NONPOR SIZE 4 STANDARD LEFT
• ETPKN3SR: EVOLUTION® MP TIB KEELED NONPOR SIZE 3 STANDARD RIGHT
• ETPKN3SL: EVOLUTION® MP TIB KEELED NONPOR SIZE 3 STANDARD LEFT
• ETPKN2SR: EVOLUTION® MP TIB KEELED NONPOR SIZE 2 STANDARD RIGHT
• ETPKN2SL: EVOLUTION® MP TIB KEELED NONPOR SIZE 2 STANDARD LEFT
• ETPKN2PR: EVOLUTION® MP TIB KEELED NONPOR SIZE 2+ RIGHT
• ETPKN2PL: EVOLUTION® MP TIB KEELED NONPOR SIZE 2+ LEFT
• ETPKN1SR: EVOLUTION® MP TIB KEELED NONPOR SIZE 1 STANDARD RIGHT
• ETPKN1SL: EVOLUTION® MP TIB KEELED NONPOR SIZE 1 STANDARD LEFT
• M684EFXSNP7R1: EFXSNP7R
• M684EFXSNP7L1: EFXSNP7L
• M684EFXSNP6R1: EFXSNP6R
• M684EFXSNP6L1: EFXSNP6L
• M684EFXSNP5R1: EFXSNP5R
• M684EFXSNP5L1: EFXSNP5L
• M684EFXSNP4R1: EFXSNP4R
• M684EFXSNP4L1: EFXSNP4L