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3.5mm Wise-Lock Proximal Tibia Plate, 8 Holes - Right
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 3.5mm Wise-Lock Proximal Tibia Plate, 8 Holes - Right FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- The plates are designed in Left & Right configuration & various length,The plates are contoured to provide a close fit with the Proximal Tibia FDA UDI
- Model / Reference
- 747.108R FDA UDITI-747.108R FDA UDI
- Description
- The plates are designed in Left & Right configuration & various length,The plates are contoured to provide a close fit with the Proximal Tibia FDA UDI
Identifiers
- Catalog Number
- A3-DND-QF-001-WF3 FDA UDI
- Primary DI / UDI-DI
- 08903993213551 FDA UDI08903993213636 FDA UDI
- 510(k) Number
- K141680 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
No
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
3.5mm Wise-Lock Proximal Tibia Plate, 8 Holes - Right by Auxein Medical Private Limited — Class II — FDA UDI — listed in FDA GUDID
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
K141680 also covers:
- 2.4mm Wise-Lock Screws, Self Tapping, Length 10 mm — Auxein Medical Private Limited
- 2.4mm Wise-Lock Screws, Self Tapping, Length 22 mm — Auxein Medical Private Limited
- 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support, 3 Ho — Auxein Medical Private Limited
- 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support, 5 Ho — Auxein Medical Private Limited
- 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support, 5 Ho — Auxein Medical Private Limited
- 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate, 14 Holes - Right — Auxein Medical Private Limited
- 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate, 9 Holes - Right — Auxein Medical Private Limited
- 2.7mm Wise-Lock Screws, Self Tapping, Length 24 mm — Auxein Medical Private Limited
- 2.7mm Wise-Lock Screws, Self Tapping, Length 42 mm — Auxein Medical Private Limited
- 3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 13 Holes - Right — Auxein Medical Private Limited
- 3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 15 Holes - Right — Auxein Medical Private Limited
- 3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 7 Holes - Left — 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 (2)
- FDA UDI 5418b1d2-cce5-4764-bc3d-470f8269cdeb 36 fields · synced Jun 8, 2026
- FDA UDI 7513a2c1-a148-4d62-a1a4-fdd5074be1e9 36 fields · synced May 22, 2026