K192335 is an FDA 510(k) clearance for the TRACKER Kyphoplasty System. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by GS Medical Co., Ltd. (Osong-Eup, Cheongwon-Gun, KR). The FDA issued a Cleared decision on December 4, 2019, 98 days after receiving the submission on August 28, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K192335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2019 |
| Decision Date | December 04, 2019 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN - Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |