| Primary Device ID | 00192629170810 |
| NIH Device Record Key | fba79b3d-531c-4741-894e-7d5f4b5812ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Evolution Revision CCK System |
| Version Model Number | E1101006 |
| Catalog Number | E1101006 |
| 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 |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com | |
| Phone | +1(866)872-0211 |
| Stephen.Weaver@ortho.microport.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192629170810 [Primary] |
| HIBCC | M684E11010061 [Previous] |
| KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
[00192629170810]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-29 |
| Device Publish Date | 2025-05-21 |
| 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 |
| 00192629170810 | EVOLUTION REVISION DISTAL SKIM SPACER CE |
| 00192629170742 | EVOLUTION REVISION DISTAL FEM RESECTION GUIDE CE |
| M684E630346R1 | EVOLUTION REV CUT THRU BUSH ADAPTER CCK SIZE 3-6 RIGHT |
| M684E630346L1 | EVOLUTION REV CUT THRU BUSH ADAPTER CCK SIZE 3-6 LEFT |
| 00192629153486 | EVOLUTION REV CCK 4 IN 1 VALGUS BUSHING |