The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for T-pal Spacer System, T-pal Titanium Spacer System, Synfix Evolution System.
| Device ID | K162358 |
| 510k Number | K162358 |
| Device Name: | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System |
| Classification | Intervertebral Fusion Device With Bone Graft, 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2016-11-01 |
| Summary: | summary |