The following data is part of a premarket notification filed by Renovis Surgical Technologies with the FDA for Renovis S141 Lumbar Interbody Fusion System.
| Device ID | K170888 |
| 510k Number | K170888 |
| Device Name: | Renovis S141 Lumbar Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Renovis Surgical Technologies 1901 W. Lugonia Redlands, CA 92374 |
| Contact | Anthony Debenedictis |
| Correspondent | Sharyn Orton MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2017-08-08 |
| Summary: | summary |