StayFuse™
GUDID 00846832009640
TORNIER, INC.
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 00846832009640 |
| NIH Device Record Key | 33890d57-a75d-4ecd-91d9-660e35d9aae1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StayFuse™ |
| Version Model Number | STA-D8 |
| 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
Device Dimensions
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832009640 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022726
FDA Product Code
| HWC | Screw, fixation, bone |
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 | 2015-10-16 |
On-Brand Devices [StayFuse™]
| 00846832009688 | STA-P4 |
| 00846832009671 | STA-P3 |
| 00846832009664 | STA-P2 |
| 00846832009657 | STA-P1 |
| 00846832009640 | STA-D8 |
| 00846832009633 | STA-D7 |
| 00846832009626 | STA-D6 |
| 00846832009619 | STA-D5 |
| 00846832009602 | STA-D4 |
| 00846832009596 | STA-D3 |
| 00846832009589 | STA-D2 |
| 00846832009572 | STA-D1 |
Trademark Results [StayFuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STAYFUSE 76007513 2611402 Dead/Cancelled |
TORNIER, INC. 2000-03-23 |
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