The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc. with the FDA for Ennovate Cervical Spinal And Occiput System.
| Device ID | K213871 |
| 510k Number | K213871 |
| Device Name: | Ennovate Cervical Spinal And Occiput System |
| Classification | Posterior Cervical 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 | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-07-01 |