The following data is part of a premarket notification filed by Renovis Surgical Technologies, Inc. with the FDA for S128 Anterior Lumbar Interbody Fusion (alif) System.
| Device ID | K140106 |
| 510k Number | K140106 |
| Device Name: | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Renovis Surgical Technologies, Inc. 200 HOMER AVE. Ashland, MA 01721 |
| Contact | Sharyn Orton |
| Correspondent | Sharyn Orton Renovis Surgical Technologies, Inc. 200 HOMER AVE. Ashland, MA 01721 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-15 |
| Decision Date | 2014-03-27 |
| Summary: | summary |