510(k) K233315
- Device
- HipXpert and HipInsight System
- Applicant
- Surgical Planning Associates, Inc.
- 510(k) number
- K233315
- Product code
- OSF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-08
- Date received
- 2023-09-29
- Regulation
- 882.4560
- Classification name
- Patient Specific Manual Orthopedic Stereotaxic System
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stephen Murphy
- Address
- New England Baptist Hospital 125 Parker Hill Ave. Suite 545 Boston MA US 02120 02120
FDA Registration Numbers#
- 3008869747
- 3016676864