Identity
- Trade Name
- VariAx®2 DR EUDAMEDVARIAX FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- VARIAX 2 DISTAL RADIUS AND VARIAX 2 DISTAL ULNA - PLATE - TITANIUM - CLASS IIB - STERILE EUDAMED
- Model / Reference
- 625132S EUDAMEDFDA UDI08858251006796UQ EUDAMED
Identifiers
- Catalog Number
- 625132S FDA UDI
- Primary DI / UDI-DI
- 07613327344493 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251006796UQ EUDAMED
- 510(k) Number
- K212581 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER 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
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 49.0 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Variax by Stryker Corp. — 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
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- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- 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
- osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica · Class II
Cleared under the same submission
K212581 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Corp.
Sources (2)
- FDA UDI 2eef4670-9c48-4e69-be99-c7d2fa09447d 35 fields · synced Oct 8, 2026
- EUDAMED 9b38e4d6-83b8-4d21-af49-577f06e8c668 61 fields · synced Oct 8, 2026