TIBIAXYS 150514SND
GUDID 10381780043836
The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. They are implanted using Newdeal locking system fixation screws and washers. This system includes as many fixation screws and washers as threaded lipped sockets on the plate. All plates and screws are manufactured from titanium alloy. The fibula plate (4 holes) is delivered sterile.
NEWDEAL
Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable, sterile Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable| Primary Device ID | 10381780043836 |
| NIH Device Record Key | 0bd9c502-3ef7-4852-b5cb-ce3e73560484 |
| Commercial Distribution Discontinuation | 2027-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TIBIAXYS |
| Version Model Number | 150514SND |
| Catalog Number | 150514SND |
| 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 | |
| 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 |
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 |
| 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 |
| 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 |
| 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. |
| 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 | 10381780043836 [Primary] |
| HIBCC | M248150514SND1 [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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