Data / Medical devices / United States / Surgical Planning Associates
Surgical Planning Associates: FDA-registered device maker in Boston, MA, United States, 3 510(k) clearances
Surgical Planning Associates is registered with the FDA (registration 3008869747) in Boston, MA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 8, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008869747
- Address
- New England Baptist Hospital 125 Parker Hill Ave Suite 545, Boston, MA, United States, 02120
- Owner or operator
- Surgical Planning Associates (10035030)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 27, 2011
- Registered through
- 2027
- Brand names listed
- HipInsight System, HipXpert
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Augmented Reality | SBF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Patient Specific Manual Orthopedic Stereotaxic System | OSF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2024 | K233315 | HipXpert and HipInsight System | OSF | Substantially Equivalent | Surgical Planning Associates, Inc. | accessdata.fda.gov |
| January 28, 2021 | K200384 | HipXpert 3D Display and Anchoring Application | OSF | Substantially Equivalent | Surgical Planning Associates, Inc. | accessdata.fda.gov |
| December 9, 2010 | K093491 | HIP SEXTANT INSTRUMENT SYSTEM | OSF | Substantially Equivalent | Surgical Planning Associates | accessdata.fda.gov |
Compare with other makers
Updated August 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.