K233315 is an FDA 510(k) clearance for the HipXpert and HipInsight System. This device is classified as a Patient Specific Manual Orthopedic Stereotaxic System (Class II - Special Controls, product code OSF).
Submitted by Surgical Planning Associates, Inc. (Boston, US). The FDA issued a Cleared decision on August 8, 2024, 314 days after receiving the submission on September 29, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Intended For Defining Orthopedic Acetabular Implant Alignment Relative To A Patient's Anatomy..
| 510(k) Number | K233315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | August 08, 2024 |
| Days to Decision | 314 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OSF - Patient Specific Manual Orthopedic Stereotaxic System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Intended For Defining Orthopedic Acetabular Implant Alignment Relative To A Patient's Anatomy. |