The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Nextar Tka Platform.
| Device ID | K202152 |
| 510k Number | K202152 |
| Device Name: | NextAR TKA Platform |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-03 |
| Decision Date | 2020-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345775702 | K202152 | 000 |
| 07630971289192 | K202152 | 000 |
| 07630971288829 | K202152 | 000 |
| 07630971288812 | K202152 | 000 |
| 07630971288805 | K202152 | 000 |
| 07630971288799 | K202152 | 000 |
| 07630971288782 | K202152 | 000 |
| 07630971288775 | K202152 | 000 |
| 07630971288768 | K202152 | 000 |
| 07630971289208 | K202152 | 000 |
| 07630971289215 | K202152 | 000 |
| 07630345775610 | K202152 | 000 |
| 07630345775696 | K202152 | 000 |
| 07630345775689 | K202152 | 000 |
| 07630345775672 | K202152 | 000 |
| 07630345775665 | K202152 | 000 |
| 07630345775658 | K202152 | 000 |
| 07630345775641 | K202152 | 000 |
| 07630345775634 | K202152 | 000 |
| 07630345775627 | K202152 | 000 |
| 07630971288751 | K202152 | 000 |