K200384 is an FDA 510(k) clearance for the HipXpert 3D Display and Anchoring Application. 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 January 28, 2021, 345 days after receiving the submission on February 18, 2020.
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 | K200384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2020 |
| Decision Date | January 28, 2021 |
| Days to Decision | 345 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. |