Identity
- Trade Name
- TIBIAXYS FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 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 lateral tibial plate is delivered sterile. FDA UDI
- Model / Reference
- 150030SND FDA UDI
- Description
- 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 lateral tibial plate is delivered sterile. FDA UDI
Identifiers
- Catalog Number
- 150030SND FDA UDI
- Primary DI / UDI-DI
- 10381780043744 FDA UDI
- 510(k) Number
- K073375 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Tibiaxys by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K073375 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI 54e50d88-f54e-4b4b-9683-5cc62d17a87e 38 fields · synced Jun 8, 2026