TIBIAXYS TIBIAXYSSET
GUDID 10381780064466
The TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. The system is indicated for fixation of bone fractures or bone reconstruction. Instruments are provided for guidance of implants.
NEWDEAL
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 10381780064466 |
| NIH Device Record Key | a4a62529-5011-41f1-a247-e61c6a10620b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TIBIAXYS |
| Version Model Number | TIBIAXYSSET |
| Catalog Number | TIBIAXYSSET |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| 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(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780064466 [Primary] |
| HIBCC | M248TIBIAXYSSET1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K022599
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
[10381780064466]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-07-16 |
| Device Publish Date | 2015-09-22 |
On-Brand Devices [TIBIAXYS]
| 10381780064466 | The TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fracture |
| 10381780048350 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048343 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048336 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048329 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048312 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048305 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048299 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048282 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048275 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048268 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048251 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048244 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780048237 | The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrod |
| 10381780043843 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043836 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043829 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043805 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043782 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043768 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043744 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043720 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043706 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
| 10381780043690 | The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and |
Trademark Results [TIBIAXYS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIBIAXYS 79055913 3612700 Live/Registered |
NEWDEAL 2008-03-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.