The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Orthopilot Next Generation, Model Fs101-fs106.
| Device ID | K080547 |
| 510k Number | K080547 |
| Device Name: | ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2008-05-23 |
| Summary: | summary |