K202184 is an FDA 510(k) clearance for the Practical Navigation Surgical Guidance System (PNSGS). This device is classified as a Orthopedic Stereotaxic Instrument (Class II - Special Controls, product code OLO).
Submitted by Practical Navigation, LLC (Superior, US). The FDA issued a Cleared decision on February 24, 2021, 204 days after receiving the submission on August 4, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw..
| 510(k) Number | K202184 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2020 |
| Decision Date | February 24, 2021 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OLO - Orthopedic Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
| Definition | Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw. |