TIBIAXYS 150255SND
GUDID 10381780048282
The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrodesis (= the transarticular screw) is made from titanium alloy. It is delivered sterile and available in different sizes.
NEWDEAL
Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | 10381780048282 |
| NIH Device Record Key | b9059fb2-f609-48da-bb54-d3f6abd0b25e |
| Commercial Distribution Discontinuation | 2027-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TIBIAXYS |
| Version Model Number | 150255SND |
| Catalog Number | 150255SND |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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(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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780048282 [Primary] |
| HIBCC | M248150255SND1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073375
FDA Product Code
| HRS | PLATE, 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 | 5 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2017-10-09 |
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 |
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