Identity
- Trade Name
- Rexious FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- CoCr Curved Rod D5.5 x 150mm FDA UDI
- Model / Reference
- A FDA UDI
- Description
- CoCr Curved Rod D5.5 x 150mm FDA UDI
Identifiers
- Catalog Number
- AC.RC.5150 FDA UDI
- Primary DI / UDI-DI
- 08800039818100 FDA UDI
- 510(k) Number
- K173131 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile 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
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: Bone-screw internal spinal fixation system, non-sterile
Rexious by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
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 777c61db-950d-40bc-b49e-9dd4d3aefab4 36 fields · synced Jun 1, 2026