The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for S4 Cervical Spinal And Occiput Systems.
| Device ID | K151938 |
| 510k Number | K151938 |
| Device Name: | S4 Cervical Spinal And Occiput Systems |
| Classification | Posterior Cervical Screw System |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa Boyle |
| Correspondent | Lisa M. Boyle 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 | 2015-07-14 |
| Decision Date | 2015-10-21 |
| Summary: | summary |