TM Ardis®
GUDID 00889024320543
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 00889024320543 |
| NIH Device Record Key | c76bd38a-015f-40a8-bbb6-948cf07d61ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TM Ardis® |
| Version Model Number | 96-701-10001 |
| Company DUNS | 793120965 |
| Company Name | ZIMMER TRABECULAR METAL TECHNOLOGY 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024320543 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113561
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
[00889024320543]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-26 |
On-Brand Devices [TM Ardis®]
| 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 |
Trademark Results [TM Ardis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TM ARDIS 85541803 4354906 Live/Registered |
Zimmer Biomet Spine, Inc. 2012-02-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.