Persona® The Personalized Knee® OsseoTi® 42-5405-000-32
GUDID 00889024646384
Zimmer, Inc.
Metal-backed patella prosthesis| Primary Device ID | 00889024646384 |
| NIH Device Record Key | 20d6e21b-9ff6-4529-95bb-a8d90ce3c41e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Persona® The Personalized Knee® OsseoTi® |
| Version Model Number | 42-5405-000-32 |
| Catalog Number | 42-5405-000-32 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024646384 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240299
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-27 |
| Device Publish Date | 2024-05-17 |
On-Brand Devices [Persona® The Personalized Knee® OsseoTi®]
| 00889024632011 | 42-5350-088-02 |
| 00889024632004 | 42-5350-088-01 |
| 00889024631991 | 42-5350-083-02 |
| 00889024631984 | 42-5350-083-01 |
| 00889024631977 | 42-5350-079-02 |
| 00889024631960 | 42-5350-079-01 |
| 00889024631953 | 42-5350-075-02 |
| 00889024631946 | 42-5350-075-01 |
| 00889024631939 | 42-5350-071-02 |
| 00889024631922 | 42-5350-071-01 |
| 00889024631915 | 42-5350-067-02 |
| 00889024631908 | 42-5350-067-01 |
| 00889024631892 | 42-5350-064-02 |
| 00889024631885 | 42-5350-064-01 |
| 00889024631878 | 42-5350-061-02 |
| 00889024631861 | 42-5350-061-01 |
| 00889024631854 | 42-5350-058-02 |
| 00889024631847 | 42-5350-058-01 |
| 00889024646414 | 42-5405-000-41 |
| 00889024646407 | 42-5405-000-38 |
| 00889024646391 | 42-5405-000-35 |
| 00889024646384 | 42-5405-000-32 |
| 00889024646377 | 42-5405-000-29 |
Trademark Results [Persona]
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