The following data is part of a premarket notification filed by Gramercy Extremity Orthopedics, Llc with the FDA for Geo Bone Screw System.
Device ID | K202817 |
510k Number | K202817 |
Device Name: | GEO Bone Screw System |
Classification | Screw, Fixation, Bone |
Applicant | Gramercy Extremity Orthopedics, LLC 1239 N. Glenville Dr. Richardson, TX 75081 |
Contact | Michael Simpson |
Correspondent | Michael Simpson Gramercy Extremity Orthopedics, LLC 1239 N. Glenville Dr. Richardson, TX 75081 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-24 |
Decision Date | 2020-10-22 |