The following data is part of a premarket notification filed by Surgical Planning Associates, Inc with the FDA for Hipxpert 3d Display And Anchoring Application.
| Device ID | K200384 |
| 510k Number | K200384 |
| Device Name: | HipXpert 3D Display And Anchoring Application |
| Classification | Patient Specific Manual Orthopedic Stereotaxic System |
| Applicant | Surgical Planning Associates, Inc New England Baptist Hospital, 125 Parker Hill Ave Suite 545 Boston, MA 02120 |
| Contact | Stephen B Murphy |
| Correspondent | Kellen Hills Orchid Design 80 Shelton Technology Center Shelton, CT 06484 |
| Product Code | OSF |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2021-01-28 |