The following data is part of a premarket notification filed by Medtech S.a. with the FDA for Rosa Surgical Device, Model Rosa 1.1.
| Device ID | K092239 |
| 510k Number | K092239 |
| Device Name: | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTECH S.A. 1006 RUE DE LA CROIX VERTE PARC EUROMEDICINE (BAT 8) Montpellier, FR 34090 |
| Contact | Bertin Nahum |
| Correspondent | Bertin Nahum MEDTECH S.A. 1006 RUE DE LA CROIX VERTE PARC EUROMEDICINE (BAT 8) Montpellier, FR 34090 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-23 |
| Decision Date | 2009-11-17 |
| Summary: | summary |