The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Exult Femoral Component Trial - Left, Exult Femoral Component Trial - Right.
Device ID | K201851 |
510k Number | K201851 |
Device Name: | EXULT Femoral Component Trial - Left, EXULT Femoral Component Trial - Right |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | Corentec Co., Ltd 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si, KR 31056 |
Contact | Sungwon Yang |
Correspondent | Sungwon Yang Corentec Co., Ltd 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si, KR 31056 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-06 |
Decision Date | 2020-07-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800068942524 | K201851 | 000 |
08800068942388 | K201851 | 000 |
08800068942371 | K201851 | 000 |
08800068942364 | K201851 | 000 |
08800068942357 | K201851 | 000 |
08800068942340 | K201851 | 000 |
08800068942333 | K201851 | 000 |
08800068942326 | K201851 | 000 |
08800068942319 | K201851 | 000 |
08800068942302 | K201851 | 000 |
08800068942289 | K201851 | 000 |
08800068942395 | K201851 | 000 |
08800068942401 | K201851 | 000 |
08800068942418 | K201851 | 000 |
08800068942517 | K201851 | 000 |
08800068942500 | K201851 | 000 |
08800068942494 | K201851 | 000 |
08800068942487 | K201851 | 000 |
08800068942470 | K201851 | 000 |
08800068942463 | K201851 | 000 |
08800068942456 | K201851 | 000 |
08800068942449 | K201851 | 000 |
08800068942432 | K201851 | 000 |
08800068942425 | K201851 | 000 |
08800068942272 | K201851 | 000 |