The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Orthopilot 2 Total Hip Arthroplasty (tha) Version 3.0.
| Device ID | K072899 |
| 510k Number | K072899 |
| Device Name: | ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. 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 | 2007-10-11 |
| Decision Date | 2008-02-06 |
| Summary: | summary |