The following data is part of a premarket notification filed by Renovis Surgical Technologies with the FDA for Renovis S180 Lateral Lumbar Interbody Fusion System.
Device ID | K181655 |
510k Number | K181655 |
Device Name: | Renovis S180 Lateral 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 | 2018-06-22 |
Decision Date | 2018-09-11 |
Summary: | summary |