K182212 is an FDA 510(k) clearance for the Geo Staple System. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Gramercy Extremity Orthopedics, LLC (Richardson, US). The FDA issued a Cleared decision on January 11, 2019, 149 days after receiving the submission on August 15, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K182212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2018 |
| Decision Date | January 11, 2019 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDR - Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |