The following data is part of a premarket notification filed by Gramercy Extremity Orthopedics, Llc with the FDA for Geo Staple System.
| Device ID | K182212 |
| 510k Number | K182212 |
| Device Name: | Geo Staple System |
| Classification | Staple, Fixation, Bone |
| Applicant | Gramercy Extremity Orthopedics, LLC 1239 N. Glenville Dr Richardson, TX 75081 |
| Contact | Michael P. Simpson |
| Correspondent | Michael P. Simpson Gramercy Extremity Orthopedics, LLC 1239 N. Glenville Dr Richardson, TX 75081 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-15 |
| Decision Date | 2019-01-11 |