Volt™ Wrist Treatment System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Volt™ Wrist Treatment System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Stainless Steel Wrist Plates EUDAMED2.4/2.7 2Column Dist Radius Plate 6Head/5Shft/Right/Std/77mm FDA UDI
- Model / Reference
- 02.426.650 EUDAMEDFDA UDI
- Description
- 2.4/2.7 2Column Dist Radius Plate 6Head/5Shft/Right/Std/77mm FDA UDI
Identifiers
- Catalog Number
- 02.426.650 FDA UDI
- Primary DI / UDI-DI
- 00196449018758 EUDAMEDFDA UDI
- Basic UDI-DI
- 01964490095E EUDAMED
- 510(k) Number
- K232693 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic fixation plate, non-bioabsorbable
Volt™ Wrist Treatment System by Tyber Medical — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
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- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K232693 also covers:
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
- Volt™ Wrist Treatment System — Tyber Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tyber Medical
Sources (2)
- FDA UDI d62455bd-b37c-45f2-b54f-755fca6fc016 36 fields · synced Jul 8, 2026
- EUDAMED e7d2a543-03d8-4f53-973a-91c052b10125 61 fields · synced Jul 8, 2026