Surgical Planning Associates, Inc.
United StatesFDA applicant, unverified FDA FEI 3008869747
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Surgical Planning Associates, Inc. makes
Surgical Planning Associates, Inc. develops software applications for preoperative planning and intraoperative guidance in orthopedic surgery, including systems for hip joint procedures. Their products feature 3D visualization tools and anchoring applications designed to assist surgeons in planning and executing hip replacements. The HipXpert 3D Display and Anchoring Application provides real-time spatial guidance, while the HipXpert and HipInsight System integrates imaging data with surgical navigation to enhance precision.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
HipXpert 3D Display and Anchoring Application Ref K200384
Regimes: 510(k) Registry: 510(k)HipXpert and HipInsight System Ref K233315
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3008869747
- Address
- New England Baptist Hospital, Boston, MA, 02120
Frequently asked questions
How many devices does Surgical Planning Associates, Inc. have in the registry?
The registry currently lists 2 devices for Surgical Planning Associates, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgical Planning Associates, Inc.'s devices?
Among its 2 most recently registered devices, Surgical Planning Associates, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Surgical Planning Associates, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Surgical Planning Associates, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgical Planning Associates, Inc. in the registry?
The most recently registered devices listed for Surgical Planning Associates, Inc. include HipXpert 3D Display and Anchoring Application and HipXpert and HipInsight System.