FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LOSPA TKR System
K Number: K212034
·
Decision Dec 9, 2021
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
33
Review Days
163
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Basic Information
- Device Name
- LOSPA TKR System
- K Number
- K212034
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corentec Co., Ltd.
- Date Received
- June 29, 2021
- Decision Date
- December 9, 2021
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Corentec Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250889 | EXULT Knee Replacement System | Apr 17, 2025 | Substantially Equivalent |
| K242401 | EXULT Knee Replacement System | Sep 12, 2024 | Substantially Equivalent |
| K242046 | EXULT Knee Replacement System | Aug 1, 2024 | Substantially Equivalent |
| K223828 | BENCOX Delta Option Heads | Mar 16, 2023 | Substantially Equivalent |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Feb 27, 2023 | Substantially Equivalent |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation | Aug 26, 2022 | Substantially Equivalent |
| K210614 | BENCOX Mirabo Z Cup Cortinium | May 24, 2022 | Substantially Equivalent |
| K220468 | BENCOX Mirabo Cup System | May 18, 2022 | Substantially Equivalent |
| K211866 | Bencox THR System | Jul 14, 2021 | Substantially Equivalent |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right | Jul 30, 2020 | Substantially Equivalent |