The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for E-gps Navigated Instruments.
| Device ID | K220862 |
| 510k Number | K220862 |
| Device Name: | E-GPS Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Precision Spine, Inc. 2050 Executive Dr. Pearl, MS 39208 |
| Contact | Michael Dawson |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-24 |
| Decision Date | 2022-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840019970761 | K220862 | 000 |
| 00840019970754 | K220862 | 000 |
| 00840019970747 | K220862 | 000 |
| 00840019970730 | K220862 | 000 |
| 00840019970723 | K220862 | 000 |
| 00840019970716 | K220862 | 000 |
| 00840019970709 | K220862 | 000 |
| 00840019970693 | K220862 | 000 |
| 00840019970686 | K220862 | 000 |