The following data is part of a premarket notification filed by Medtech S.a. with the FDA for Rosa One Spine Application.
| Device ID | K192173 |
| 510k Number | K192173 |
| Device Name: | ROSA ONE Spine Application |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MEDTECH S.A. ZAC Eureka - 900 Rue Du Mas De Verchant Montpellier, FR 34000 |
| Contact | Serge Tabet |
| Correspondent | Serge Tabet MEDTECH S.A ZAC Eureka - 900 Rue Du Mas De Verchant Montpellier, FR 34000 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2019-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760244032942 | K192173 | 000 |
| 03760244034304 | K192173 | 000 |
| 03760244033383 | K192173 | 000 |
| 03760244034120 | K192173 | 000 |
| 03760244032980 | K192173 | 000 |
| 03760244033505 | K192173 | 000 |
| 03760244033512 | K192173 | 000 |
| 03760244033581 | K192173 | 000 |
| 03760244034038 | K192173 | 000 |
| 03760244033765 | K192173 | 000 |
| 03760244030245 | K192173 | 000 |
| 03760244030252 | K192173 | 000 |
| 03760244031785 | K192173 | 000 |
| 03760244034144 | K192173 | 000 |