The following data is part of a premarket notification filed by Aesculap Implant Systems with the FDA for Aesculap Implant Systems S4 Spinal System.
| Device ID | K100623 |
| 510k Number | K100623 |
| Device Name: | AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP IMPLANT SYSTEMS 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| 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 | 2010-03-04 |
| Decision Date | 2010-06-09 |
| Summary: | summary |