Identity
- Trade Name
- LOSPA Knee System FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- Tibial insert trial-Fixed-CR-SZ 12-8T FDA UDI
- Model / Reference
- 01.62.1C0 FDA UDI
- Description
- Tibial insert trial-Fixed-CR-SZ 12-8T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806373897849 FDA UDI
- 510(k) Number
- K110404 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Knee tibia prosthesis trial, reusable
LOSPA Knee System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee tibia prosthesis trial, reusable.
- JOURNEY — Smith & Nephew, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- U2™ Knee — UNITED ORTHOPEDIC CORP. · Class II
- ACS® — implantcast GmbH · Class I
- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- SIGMA — DEPUY ORTHOPAEDICS, INC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
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
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 14cecdab-b2de-4007-9edc-acd58e09f590 35 fields · synced Jun 1, 2026