Identity
- Trade Name
- AEON-C FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- AEON-C Stand Alone; TAV; 15x18; 15deg; H9 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- AEON-C Stand Alone; TAV; 15x18; 15deg; H9 FDA UDI
Identifiers
- Catalog Number
- CSAT.15181509 FDA UDI
- Primary DI / UDI-DI
- 08800039836524 FDA UDI
- 510(k) Number
- K191477 FDA UDI
- FDA Product Code
- OVE FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
MR Unsafe FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
Aeon-C by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
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- Cervalign — Xtant Medical Holdings, Inc. · Class II
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- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Cleared under the same submission
K191477 also covers:
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
- AEON-C — Dio Medical Co., Ltd.
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
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI d327d577-9137-42cd-b8d2-e5be9437b708 36 fields · synced Jun 1, 2026