Trabecular Metal™
GUDID 00889024195592
Zimmer, Inc.
Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic| Primary Device ID | 00889024195592 |
| NIH Device Record Key | 7a318baa-e86b-4959-88f9-763c2837b0dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trabecular Metal™ |
| Version Model Number | 00-5850-003-10 |
| 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 | 00889024195592 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110940
FDA Product Code
| KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, 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 | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2015-09-17 |
On-Brand Devices [Trabecular Metal™]
Trademark Results [Trabecular Metal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRABECULAR METAL 77088681 not registered Dead/Abandoned |
Zimmer Technology, Inc. 2007-01-23 |
 TRABECULAR METAL 77087660 3483007 Live/Registered |
Zimmer, Inc. 2007-01-22 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.