Identity
- Trade Name
- ARIX Elbow System Bone Plate FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 35-DMHU-104-R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806390881272 FDA UDI
- 510(k) Number
- K201656 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile 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
No
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, non-sterile
ARIX Elbow System Bone Plate by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
- CANNULATED SCREW SYSTEM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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- ORTHOLOC — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- SAMPEDRO — Industrias Medicas Sampedro S.A.S · Class II
- TUBULAR PLATE — Biomet Orthopedics, Inc. · Class II
- APTUS — Medartis Inc. · Class II
- 3.5 LC TI polyaxial locking plate, str., 20 h., 242mm — mahe medical gmbh · Class II
- TC-100 — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K201656 also covers:
- ARIX Elbow System Bone Plate — Jeil Medical Corporation
- ARIX Elbow System Bone Plate — Jeil Medical Corporation
- ARIX Elbow System Bone Plate — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
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
- Jeil Medical Corporation
Sources (1)
- FDA UDI 0fdc4ef7-8ae2-4b8f-acd9-1ca3ccaaa6b9 33 fields · synced May 30, 2026