The following data is part of a premarket notification filed by Practical Navigation, Llc with the FDA for Practical Navigation Surgical Guidance System (pnsgs).
| Device ID | K202184 |
| 510k Number | K202184 |
| Device Name: | Practical Navigation Surgical Guidance System (PNSGS) |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Practical Navigation, LLC 720 E. Wiggins Street Superior, CO 80027 |
| Contact | Brad Clayton |
| Correspondent | Roger N. White Phiama, Inc 236 McKinley Park Lane Louisville, CO 80027 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-04 |
| Decision Date | 2021-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850026574364 | K202184 | 000 |
| 00850026574142 | K202184 | 000 |
| 00850026574135 | K202184 | 000 |
| 00850026574500 | K202184 | 000 |
| 00850026574715 | K202184 | 000 |
| 00850026574579 | K202184 | 000 |
| 00850026574555 | K202184 | 000 |
| 00850026574722 | K202184 | 000 |
| 00850026574708 | K202184 | 000 |
| 00850026574692 | K202184 | 000 |
| 00850026574685 | K202184 | 000 |
| 00850026574678 | K202184 | 000 |
| 00850026574159 | K202184 | 000 |
| 00850026574166 | K202184 | 000 |
| 00850026574173 | K202184 | 000 |
| 00850026574357 | K202184 | 000 |
| 00850026574340 | K202184 | 000 |
| 00850026574333 | K202184 | 000 |
| 00850026574258 | K202184 | 000 |
| 00850026574241 | K202184 | 000 |
| 00850026574234 | K202184 | 000 |
| 00850026574227 | K202184 | 000 |
| 00850026574210 | K202184 | 000 |
| 00850026574203 | K202184 | 000 |
| 00850026574197 | K202184 | 000 |
| 00850026574180 | K202184 | 000 |
| 00850026574661 | K202184 | 000 |