The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synfix Evolution Secured Spacer System.
| Device ID | K150673 |
| 510k Number | K150673 |
| Device Name: | SYNFIX Evolution Secured Spacer System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | SYNTHES (USA) PRODUCTS LLC 325 Paramount Drive Raynham, MA 02767 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang SYNTHES (USA) PRODUCTS LLC 325 Paramount Drive Raynham, MA 02767 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2015-08-21 |
| Summary: | summary |