The following data is part of a premarket notification filed by G Surgical Llc with the FDA for G Surgical Marksman Mis System.
Device ID | K161516 |
510k Number | K161516 |
Device Name: | G Surgical Marksman MIS System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | G SURGICAL LLC 5757 Central Ave, Suite G Boulder, CO 80301 |
Contact | Donald Grafton |
Correspondent | Karen E. Warden, Ph.d. BackRoads Consulting Inc. P.O. Box 566 Chesterland, OH 44026 |
Product Code | NKB |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-02 |
Decision Date | 2016-08-25 |
Summary: | summary |