Identity
- Trade Name
- LOSPA Knee System FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- Tibial keel punch - S FDA UDI
- Model / Reference
- 01.61.183 FDA UDI
- Description
- Tibial keel punch - S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806373889783 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic broach 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: Orthopaedic broach
LOSPA Knee System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic broach.
- EcoFit® broach for short stem 133° — implantcast GmbH · Class I
- PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- Equinoxe — Exactech, Inc. · Class II
- Anthology — Smith & Nephew, Inc. · Class I
- Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- iNSitu™ Hip System — Nextstep Arthropedix · Class I
- TEMA Elbow — Limacorporate · Class II
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 34898841-fa78-4b27-a21a-b37fe8b65916 35 fields · synced May 30, 2026