K233315
- 510(k) number
- K233315
- Device name
- HipXpert and HipInsight System
- Applicant
- Surgical Planning Associates, Inc. MA · US
- Product code
- OSF — Patient Specific Manual Orthopedic Stereotaxic Syste
- Decision date
- 2024-08-08
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233315.pdf
Official FDA record: K233315
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.