Identity
- Trade Name
- ARIX System Bone Screw FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 28-SO-S63-T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800089432912 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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 bone screw, non-bioabsorbable, non-sterile
ARIX System Bone Screw by Jeil Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · 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 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
K221920 also covers:
- 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
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
- ARIX System Bone Screw — Jeil Medical Corporation
K231441 also covers:
- ARIX Ankle 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jeil Medical Corporation
Sources (1)
- FDA UDI 35fca153-1508-4ae0-ab1b-e64e5f954f81 33 fields · synced May 29, 2026