The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Aesculap(r) Implant Systems (ais) S4 Navigation Instruments.
| Device ID | K153700 |
| 510k Number | K153700 |
| Device Name: | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-07-08 |
| Summary: | summary |