EVOLUTION ETPSB2PR

GUDID M684ETPSB2PR1

Microport Orthopedics Inc.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: M684ETPSB2PR1
• NIH Device Record Key: c88f8aa1-2f64-44a8-850c-2fafc8b82605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVOLUTION
• Version Model Number: ETPSB2PR
• Catalog Number: ETPSB2PR
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M684ETPSB2PR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152298

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-06-20

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