The following data is part of a premarket notification filed by Spineart with the FDA for Perla Posterior Cervico-thoracic Fixation System.
| Device ID | K153386 |
| 510k Number | K153386 |
| Device Name: | Perla Posterior Cervico-Thoracic Fixation System |
| Classification | Posterior Cervical Screw System |
| Applicant | SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS, CP1813 Geneva, CH 1215 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS - CP 1813 Geneva 15, CH 1215 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2016-01-25 |
| Summary: | summary |