The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Spineology Navigation Instruments.
Device ID | K180796 |
510k Number | K180796 |
Device Name: | Spineology Navigation Instruments |
Classification | Orthopedic Stereotaxic Instrument |
Applicant | Spineology Inc. 7800 3rd Street N., Suite 600 St. Paul, MN 55128 |
Contact | Jacqueline A. Hauge |
Correspondent | Jacqueline A. Hauge Spineology, Inc. 7800 3rd Street N., Suite 600 St. Paul, MN 55128 |
Product Code | OLO |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-27 |
Decision Date | 2018-05-02 |
Summary: | summary |