The following data is part of a premarket notification filed by Domino S.r.l. with the FDA for Globus Genesy 1100 Stimulator.
| Device ID | K071431 |
| 510k Number | K071431 |
| Device Name: | GLOBUS GENESY 1100 STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | DOMINO S.R.L. 18 EUSTACE DRIVE West Hartford, CT 06110 |
| Contact | Giovanni M Ciriani |
| Correspondent | Giovanni M Ciriani DOMINO S.R.L. 18 EUSTACE DRIVE West Hartford, CT 06110 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-23 |
| Decision Date | 2007-09-21 |
| Summary: | summary |