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2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,4 holes FDA UDI
- Model / Reference
- Ti-546.204R FDA UDI
- Description
- 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,4 holes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08903993359051 FDA UDI
- 510(k) Number
- K211324 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h by Auxein Medical Private Limited — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- 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
K211324 also covers:
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 10mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 12mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 18mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 22mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Hex Head, 8mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 14mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 20mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 22mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 26mm length — Auxein Medical Private Limited
- 2.4 mm Cortical Screw, Self-tapping, Star Head, 28mm length — Auxein Medical Private Limited
- 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right), 3 hole — Auxein Medical Private Limited
- 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left), 4 holes — Auxein Medical Private Limited
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
- Auxein Medical Private Limited
Sources (1)
- FDA UDI fa8ad6b0-6f57-4711-a8b8-d3c655a21a71 35 fields · synced May 31, 2026