AEQUALIS™ PerFORM Reversed
GUDID 00846832060818
TORNIER, INC.
Orthopaedic bone screw, non-bioabsorbable, non-sterile| Primary Device ID | 00846832060818 |
| NIH Device Record Key | 429982e9-e7a8-484b-9705-7f146d9a5ba2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AEQUALIS™ PerFORM Reversed |
| Version Model Number | DWJ135 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com |
Device Dimensions
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 6.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832060818 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161742
FDA Product Code
| PHX | shoulder prosthesis, reverse configuration |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-21 |
On-Brand Devices [AEQUALIS™ PerFORM Reversed]
Trademark Results [AEQUALIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AEQUALIS 87686345 5497682 Live/Registered |
Nutrition DNA Pty Ltd. 2017-11-15 |
 AEQUALIS 86159677 4927977 Live/Registered |
CCP2, LLC 2014-01-07 |
 AEQUALIS 85437537 not registered Dead/Abandoned |
M&H Management Limited 2011-10-03 |
 AEQUALIS 77730372 not registered Dead/Abandoned |
M&H Management Limited 2009-05-06 |
 AEQUALIS 74670341 2178808 Dead/Cancelled |
AEQUALIS FURNITURE, L.L.C. 1995-05-05 |
 AEQUALIS 74536909 2055775 Live/Registered |
TORNIER 1994-06-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.