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 |