The following data is part of a premarket notification filed by Gramercy Extremity Orthopedics, Llc with the FDA for Geo Firstfuse 1st Mtp Joint Arthrodesis Plating System.
| Device ID | K210534 |
| 510k Number | K210534 |
| Device Name: | GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Gramercy Extremity Orthopedics, LLC 1239 N Glenville Dr Richardson, TX 75081 |
| Contact | Michael P. Simpson |
| Correspondent | Tamala J. Wampler Novus Management Group, LLC 4480 Lake Forest Drive, Ste. 412 Blue Ash, OH 45242 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-24 |
| Decision Date | 2021-03-26 |