The following data is part of a premarket notification filed by Amplitude with the FDA for Anatomic Total Knee System.
| Device ID | K161414 |
| 510k Number | K161414 |
| Device Name: | Anatomic Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | AMPLITUDE 11 COURS JACQUES OFFENBACH Valence, FR 26000 |
| Contact | Mireille Lemery |
| Correspondent | Mireille Lemery AMPLITUDE 11 COURS JACQUES OFFENBACH Valence, FR 26000 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2017-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701089500807 | K161414 | 000 |
| 03701089500098 | K161414 | 000 |
| 03701089500081 | K161414 | 000 |
| 03701089500074 | K161414 | 000 |
| 03701089500067 | K161414 | 000 |
| 03701089500050 | K161414 | 000 |
| 03701089500043 | K161414 | 000 |
| 03701089500036 | K161414 | 000 |
| 03701089500029 | K161414 | 000 |
| 03701089500012 | K161414 | 000 |
| 03701089500005 | K161414 | 000 |
| 03701089500845 | K161414 | 000 |
| 03701089500838 | K161414 | 000 |
| 03701089500821 | K161414 | 000 |
| 03701089500104 | K161414 | 000 |
| 03701089500111 | K161414 | 000 |
| 03701089500128 | K161414 | 000 |
| 03701089500791 | K161414 | 000 |
| 03701089500784 | K161414 | 000 |
| 03701089500777 | K161414 | 000 |
| 03701089500760 | K161414 | 000 |
| 03701089500753 | K161414 | 000 |
| 03701089500746 | K161414 | 000 |
| 03701089500739 | K161414 | 000 |
| 03701089500722 | K161414 | 000 |
| 03701089500173 | K161414 | 000 |
| 03701089500166 | K161414 | 000 |
| 03701089500159 | K161414 | 000 |
| 03701089500142 | K161414 | 000 |
| 03701089500135 | K161414 | 000 |
| 03701089500814 | K161414 | 000 |