| Primary Device ID | 00889024320635 |
| NIH Device Record Key | 4e8b54be-e857-4fd4-893a-1ff2cf5a7279 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TM Ardis® |
| Version Model Number | 96-701-30001 |
| Company DUNS | 793120965 |
| Company Name | ZIMMER TRABECULAR METAL TECHNOLOGY INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024320635 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
[00889024320635]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2016-06-13 |
| 00889024320635 | 96-701-30001 |
| 00889024320628 | 96-701-21161 |
| 00889024320611 | 96-701-21121 |
| 00889024320604 | 96-701-21101 |
| 00889024320598 | 96-701-21081 |
| 00889024320581 | 96-701-20161 |
| 00889024320574 | 96-701-20121 |
| 00889024320567 | 96-701-20101 |
| 00889024320550 | 96-701-20081 |
| 00889024320543 | 96-701-10001 |
| 00889024223813 | 96-701-31001 |
| 00889024223806 | 96-701-06071 |
| 00889024223790 | 96-701-05071 |
| 00889024223783 | 96-701-04071 |
| 00889024223776 | 96-701-03071 |
| 00889024223769 | 96-701-02071 |
| 00889024223752 | 96-701-01071 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TM ARDIS 85541803 4354906 Live/Registered |
Zimmer Biomet Spine, Inc. 2012-02-14 |