Trabecular Metal™
GUDID 00889024405561
Zimmer, Inc.
Reverse shoulder prosthesis base plate| Primary Device ID | 00889024405561 |
| NIH Device Record Key | 330ff3ed-1f72-4204-a921-9af95819abe3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trabecular Metal™ |
| Version Model Number | 00-4349-020-02 |
| 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 Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024405561 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121543
FDA Product Code
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-25 |
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.