The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Nextar Rsa Platform.
| Device ID | K210153 |
| 510k Number | K210153 |
| Device Name: | NextAR RSA 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 |
| Subsequent Product Code | JWH |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | PBF |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2021-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345731227 | K210153 | 000 |
| 07630542702211 | K210153 | 000 |
| 07630345727541 | K210153 | 000 |
| 07630345727558 | K210153 | 000 |
| 07630345731104 | K210153 | 000 |
| 07630345731111 | K210153 | 000 |
| 07630345731128 | K210153 | 000 |
| 07630345731135 | K210153 | 000 |
| 07630345731142 | K210153 | 000 |
| 07630345731159 | K210153 | 000 |
| 07630345731166 | K210153 | 000 |
| 07630345731173 | K210153 | 000 |
| 07630345731180 | K210153 | 000 |
| 07630345731197 | K210153 | 000 |
| 07630345731203 | K210153 | 000 |
| 07630345731210 | K210153 | 000 |
| 07630542702204 | K210153 | 000 |