The following data is part of a premarket notification filed by Renovis Surgical Technologies with the FDA for Renovis S141 Lumbar Interbody Cage System.
Device ID | K143126 |
510k Number | K143126 |
Device Name: | Renovis S141 Lumbar Interbody Cage System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Renovis Surgical Technologies 1901 W. Lugonia Ave., Ste 340 Redlands, CA 92374 |
Contact | Josh Brown |
Correspondent | Rich Jansen Silver Pine Consulting 11821 Bramble Cove Drive Ft. Myers, FL 33905 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-31 |
Decision Date | 2015-02-06 |
Summary: | summary |