510(k) K200384
K200384 is an FDA 510(k) premarket notification submitted by Surgical Planning Associates, Inc. for the device "HipXpert 3D Display and Anchoring Application". The FDA issued a decision of Substantially Equivalent on January 28, 2021. The device falls under product code OSF (Patient Specific Manual Orthopedic Stereotaxic System), a Class II device regulated under 21 CFR 882.4560. Surgical Planning Associates, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2021
- Date Received
- February 18, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Patient Specific Manual Orthopedic Stereotaxic System
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- OR
- Submission Type
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.