Identity
- Trade Name
- BENCOX Hip System FDA UDI
- Generic Name
- Screwing power tool attachment FDA UDI
- Device Name
- Drill bit 30mm FDA UDI
- Model / Reference
- 01.51.174 FDA UDI
- Description
- Drill bit 30mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806373880919 FDA UDI
- 510(k) Number
- K150007 FDA UDI
- FDA Product Code
- LZO FDA UDIKWY FDA UDILPH FDA UDI
- GMDN Term
- Screwing power tool attachment FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 FDA UDI888.3358 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: Screwing power tool attachment
BENCOX Hip System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screwing power tool attachment.
- MIS — MIS Implants Technologies Ltd. · Class I
- MIS — MIS Implants Technologies Ltd. · Class I
- MIS — MIS Implants Technologies Ltd. · Class I
- Drill Bit Kit, 3.5mm — FLOWER ORTHOPEDICS CORPORATION · Class I
- Power Driver G-Wire Kit, 3.0-4.5mm Cannulated Screws — FLOWER ORTHOPEDICS CORPORATION · Class I
- MIS — MIS Implants Technologies Ltd. · Class I
- MIS — MIS Implants Technologies Ltd. · Class I
- Zimmer® Cannulated Screw System — Pioneer Surgical Technology, Inc. · Class I
Cleared under the same submission
K150007 also covers:
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip System — Corentec Co., Ltd
- BENCOX Hip 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 c7be13b4-fefa-481b-a188-8e203ae1e16c 35 fields · synced May 30, 2026