FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
LOSPA Modular Knee System
K Number: K160157
·
Decision Dec 1, 2016
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
33
Review Days
314
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Basic Information
- Device Name
- LOSPA Modular Knee System
- K Number
- K160157
- 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
- January 22, 2016
- Decision Date
- December 1, 2016
- 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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|---|---|---|---|
| K250889 | EXULT Knee Replacement System | Apr 17, 2025 | Substantially Equivalent |
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| 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 |
| K212034 | LOSPA TKR System | Dec 9, 2021 | Substantially Equivalent |
| K211866 | Bencox THR System | Jul 14, 2021 | Substantially Equivalent |