Identity
- Trade Name
- LOSPA Knee System FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- Template 120% FDA UDI
- Model / Reference
- 01.61.237 FDA UDI
- Description
- Template 120% FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806373894183 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
No
FDA UDI
Category: Surgical implant template, reusable
LOSPA Knee System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical implant template, reusable.
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Cleared under the same submission
K110404 also covers:
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
K121037 also covers:
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
K130673 also covers:
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Knee System — Corentec Co., Ltd
- LOSPA Total Knee System — Corentec Co., Ltd
- LOSPA Total Knee System — Corentec Co., Ltd
- LOSPA Total Knee System — Corentec Co., Ltd
- LOSPA Total Knee System — Corentec Co., Ltd
- LOSPA Total Knee System — Corentec Co., Ltd
- LOSPA Total Knee System — Corentec Co., Ltd
- LOSPA Total Knee 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corentec Co., Ltd
Sources (1)
- FDA UDI 958b4eba-d892-4d29-929c-ee916a33e35a 35 fields · synced May 30, 2026