The following data is part of a premarket notification filed by Aesculap Implant System, Inc. with the FDA for Orthopilot Next Generation-uka Software, Model Fs210.
| Device ID | K090375 |
| 510k Number | K090375 |
| Device Name: | ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | AESCULAP IMPLANT SYSTEM, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP IMPLANT SYSTEM, INC. 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 | 2009-02-17 |
| Decision Date | 2009-06-23 |
| Summary: | summary |