Identity
- Trade Name
- Rexious FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Rod Straight (CoCr) (D)5.5x(L)290mm-Ø5.5 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Rod Straight (CoCr) (D)5.5x(L)290mm-Ø5.5 FDA UDI
Identifiers
- Catalog Number
- AC.RA.0290 FDA UDI
- Primary DI / UDI-DI
- 08800113949232 FDA UDI
- 510(k) Number
- K173131 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
Rexious 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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- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
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Cleared under the same submission
K173131 also covers:
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — Dio Medical Co., Ltd.
- Rexious — 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 b37b6a35-b31c-4c77-9724-6976f00b3713 36 fields · synced May 30, 2026