The following data is part of a premarket notification filed by Surgical Planning Associates with the FDA for Hip Sextant Instrument System.
| Device ID | K093491 |
| 510k Number | K093491 |
| Device Name: | HIP SEXTANT INSTRUMENT SYSTEM |
| Classification | Patient Specific Manual Orthopedic Stereotaxic System |
| Applicant | SURGICAL PLANNING ASSOCIATES 80 SHELTON TECHNOLOGY CENTER Medford, MA 02155 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary SURGICAL PLANNING ASSOCIATES 80 SHELTON TECHNOLOGY CENTER Medford, MA 02155 |
| Product Code | OSF |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-10 |
| Decision Date | 2010-12-09 |
| Summary: | summary |