510(k) K212034
K212034 is an FDA 510(k) premarket notification submitted by Corentec Co., Ltd. for the device "LOSPA TKR System". The FDA issued a decision of Substantially Equivalent on Dec 9, 2021. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Corentec Co., Ltd. has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 9, 2021
- Date Received
- Jun 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type
- 510(k)