The following data is part of a premarket notification filed by Gs Medical Co., Ltd. with the FDA for Tracker Kyphoplasty System.
| Device ID | K192335 |
| 510k Number | K192335 |
| Device Name: | TRACKER Kyphoplasty System |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | GS Medical Co., Ltd. 90, Osongsaengmyeong 4-ro Osong-eup, Cheongwon-gun, KR 363-951 |
| Contact | Andrea Watt |
| Correspondent | Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01860 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-28 |
| Decision Date | 2019-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806395400980 | K192335 | 000 |
| 08806162110722 | K192335 | 000 |
| 08806162110920 | K192335 | 000 |
| 08806162110944 | K192335 | 000 |
| 08806162110999 | K192335 | 000 |
| 08806162111019 | K192335 | 000 |
| 08806162111033 | K192335 | 000 |
| 08806162111217 | K192335 | 000 |
| 08806162111293 | K192335 | 000 |
| 08806162111309 | K192335 | 000 |
| 08806162111316 | K192335 | 000 |
| 08806162111392 | K192335 | 000 |
| 08806162110708 | K192335 | 000 |