Identity
- Trade Name
- LOSPA IS Spinal System FDA UDI
- Generic Name
- External spinal fixation system FDA UDI
- Device Name
- MIS ANTI TORQUE WRENCH FDA UDI
- Model / Reference
- SI.MP6.0012 FDA UDI
- Description
- MIS ANTI TORQUE WRENCH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017299990 FDA UDI
- FDA Product Code
- HXC FDA UDI
- GMDN Term
- External spinal fixation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Yes
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: External spinal fixation system
LOSPA IS Spinal System by Corentec Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External spinal fixation system.
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- King Cobra — EMINENT SPINE LLC · Class II
- 4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
- Fang Plate — EMINENT SPINE LLC · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Corentec Co., Ltd
Sources (1)
- FDA UDI 83b5ac6e-4faa-428c-9710-d6632e38196e 34 fields · synced May 30, 2026