Identity
- Trade Name
- BENCOX THR System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Bencox Mirabo PE Liner Trial 28C+-ELV15-PPX FDA UDI
- Model / Reference
- HA.01L.2842 FDA UDI
- Description
- Bencox Mirabo PE Liner Trial 28C+-ELV15-PPX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800068958587 FDA UDI
- 510(k) Number
- K211866 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDIKWY FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI888.3390 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Surgical implant/trial-implant/sizer holder, reusable
BENCOX THR System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, reusable.
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- ARx — Life Spine, Inc. · Class II
- APEX 3D Total Ankle Replacement System — Paragon 28 · Class II
- JULIET INSTRUMENTATION — Spineart · Class II
- JOURNEY II XR — Smith & Nephew, Inc. · Class II
- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- DISTAL TIBIAL PLATE HANDLE, RIGHT — Biomet Orthopedics, Inc. · Class I
Cleared under the same submission
K211866 also covers:
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec Co., Ltd
- BENCOX THR System — Corentec 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
- Corentec Co., Ltd
Sources (1)
- FDA UDI 2d10c2a3-8c22-46a0-b970-baa8fe3c1be8 35 fields · synced Jun 1, 2026