The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Aesculap Orthopilot Next Generation.
| Device ID | K141694 |
| 510k Number | K141694 |
| Device Name: | AESCULAP ORTHOPILOT NEXT GENERATION |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Julie Tom Wing |
| Correspondent | Julie Tom Wing AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-24 |
| Decision Date | 2015-02-24 |
| Summary: | summary |