The following data is part of a premarket notification filed by Gs Medical Co. Ltd. with the FDA for Tracker Plus Kyphoplasty System.
| Device ID | K211797 |
| 510k Number | K211797 |
| Device Name: | TRACKER Plus Kyphoplasty System |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | GS Medical Co. Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Sam Camp |
| Correspondent | Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-10 |
| Decision Date | 2021-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809695630231 | K211797 | 000 |
| 08809695574597 | K211797 | 000 |
| 08809695574573 | K211797 | 000 |
| 08809695574566 | K211797 | 000 |
| 08809695574559 | K211797 | 000 |
| 08809695574542 | K211797 | 000 |
| 08809695574535 | K211797 | 000 |
| 08809695574528 | K211797 | 000 |
| 08809695574511 | K211797 | 000 |
| 08809695574504 | K211797 | 000 |
| 08800104089480 | K211797 | 000 |
| 08809695574603 | K211797 | 000 |
| 08809695574641 | K211797 | 000 |
| 08809695576454 | K211797 | 000 |
| 08809695619939 | K211797 | 000 |
| 08809695619861 | K211797 | 000 |
| 08809695619830 | K211797 | 000 |
| 08809695619748 | K211797 | 000 |
| 08809695579998 | K211797 | 000 |
| 08809695579806 | K211797 | 000 |
| 08809695579790 | K211797 | 000 |
| 08809695579783 | K211797 | 000 |
| 08809695579776 | K211797 | 000 |
| 08809695579769 | K211797 | 000 |
| 08800104089473 | K211797 | 000 |