The following data is part of a premarket notification filed by Renovo Life Llc with the FDA for Renovo Life Small Bone Im Nail System.
| Device ID | K161254 |
| 510k Number | K161254 |
| Device Name: | Renovo Life Small Bone IM Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Renovo Life LLC 1104 Spruce Street Belmont, NC 28012 |
| Contact | Harold Crowder |
| Correspondent | Donald W. Guthner Orgenix, LLC 111 Hill Road Douglassville, PA 19518 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-03 |
| Decision Date | 2016-11-07 |
| Summary: | summary |