Identity
- Trade Name
- LOSPA TKR SYSTEM FDA UDI
- Generic Name
- Knee tibia prosthesis trial, reusable FDA UDI
- Device Name
- Tibial Insert Trial PS #06 T12 FDA UDI
- Model / Reference
- KA.SPS.0612 FDA UDI
- Description
- Tibial Insert Trial PS #06 T12 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800068955012 FDA UDI
- 510(k) Number
- K212034 FDA UDI
- FDA Product Code
- HWT FDA UDIJWH FDA UDI
- GMDN Term
- Knee tibia prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI888.3560 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 Tkr System by Corentec Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Knee tibia prosthesis trial, reusable.
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- 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
K212034 also covers:
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR SYSTEM — Corentec Co., Ltd
- LOSPA TKR 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 I | Pending data |
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Manufacturer
- Manufacturer
- Corentec Co., Ltd
Sources (1)
- FDA UDI 750b6abf-9a9b-4df3-8dcc-3f1a7ccdb5b9 35 fields · synced May 30, 2026