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 |