Identity
- Trade Name
- Huvex FDA UDI
- Generic Name
- Lumbar interspinous decompression spacer, non-sterile FDA UDI
- Device Name
- IMPLANT HOLDER RIGHT FDA UDI
- Model / Reference
- A FDA UDI
- Description
- IMPLANT HOLDER RIGHT FDA UDI
Identifiers
- Catalog Number
- SO.IN.0002 FDA UDI
- Primary DI / UDI-DI
- 08809489294878 FDA UDI
- 510(k) Number
- K162849 FDA UDI
- FDA Product Code
- PEK FDA UDI
- GMDN Term
- Lumbar interspinous decompression spacer, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 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
MR Unsafe FDA UDI
Category: Lumbar interspinous decompression spacer, non-sterile
Huvex by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162849 also covers:
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — Dio Medical Co., Ltd.
- Huvex — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI b68c2412-fc37-43f7-ab83-73ad83a038b8 36 fields · synced May 31, 2026