The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Lateral Synfix.
| Device ID | K131276 |
| 510k Number | K131276 |
| Device Name: | LATERAL SYNFIX |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Monika Mcdole-russell |
| Correspondent | Monika Mcdole-russell SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2014-01-06 |
| Summary: | summary |