MG II® 00-5110-023-15
GUDID 00889024435827
Zimmer, Inc.
Tibial insert| Primary Device ID | 00889024435827 |
| NIH Device Record Key | b620a28b-721e-44fe-8ca6-89839b0aeb2c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MG II® |
| Version Model Number | 5110-23-15 |
| Catalog Number | 00-5110-023-15 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, 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 | 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024435827 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K892800
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-04 |
| Device Publish Date | 2021-09-25 |
On-Brand Devices [MG II®]
Trademark Results [MG II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MG II 74144880 1677487 Live/Registered |
ZIMMER, INC. 1991-03-06 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.