ENNOVATE®
Thoracolumbosacral Pedicle Screw System
Aesculap Implant Systems, LLC
The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Ennovate®.
Pre-market Notification Details
| Device ID | K180433 |
| 510k Number | K180433 |
| Device Name: | ENNOVATE® |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Melanie Burkert |
| Correspondent | Melanie Burkert Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-20 |
| Decision Date | 2018-04-26 |
| Summary: | summary |
Trademark Results [ENNOVATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENNOVATE 97181456 not registered Live/Pending |
Entain Marketing (UK) Limited 2021-12-20 |
 ENNOVATE 85462622 4204878 Dead/Cancelled |
Empower Ennovation, LLC 2011-11-02 |
 ENNOVATE 79152092 4797260 Live/Registered |
Aesculap AG 2014-03-11 |
 ENNOVATE 76206584 not registered Dead/Abandoned |
Ennovate Networks, Inc. 2001-02-08 |
 ENNOVATE 76206583 not registered Dead/Abandoned |
Ennovate Networks, Inc. 2001-02-08 |
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