The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Ennovate Spinal System.
| Device ID | K162134 |
| 510k Number | K162134 |
| Device Name: | ENNOVATE Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Paul Amudala |
| Correspondent | Paul Amudala Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | NKB |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2016-12-14 |
| Summary: | summary |