Identity
- Trade Name
- Lospa Modular Knee System FDA UDI
- Generic Name
- Osteotomy guide, reusable FDA UDI
- Device Name
- Femoral AP Cutting Guide #11 FDA UDI
- Model / Reference
- KB.SFC.E011 FDA UDI
- Description
- Femoral AP Cutting Guide #11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800068972330 FDA UDI
- FDA Product Code
- HTZ FDA UDI
- GMDN Term
- Osteotomy guide, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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: Osteotomy guide, reusable
Lospa Modular Knee System by Corentec Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Osteotomy guide, reusable.
- Legion — Smith & Nephew, Inc. · Class II
- MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class II
- Persona® — Zimmer, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- Profix — Smith & Nephew, Inc. · Class II
- QUANTUM — IN2BONES · Class I
- Cut Guide — TREACE MEDICAL CONCEPTS, INC. · Class I
- UKNEE™ — UNITED ORTHOPEDIC CORP. · Class I
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 5e940120-7fdc-4986-9f5e-16e365828442 34 fields · synced May 30, 2026