TRACKER Plus Kyphoplasty System
FDA 510(k) K211797 · GS Medical Co., Ltd.
510(k) numberK211797
Submission
- Device name
- TRACKER Plus Kyphoplasty System
- Applicant
- GS Medical Co., Ltd.
Cheongju-Si, KR - Received
- June 10, 2021
- Decision date
- October 28, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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| K200592 | GS Medical AnyPlus PEEK Cage SystemODP · Traditional | 08/10/2020SE |
| K192335 | TRACKER Kyphoplasty SystemNDN · Traditional | 12/04/2019SE |
| K190170 | MVP Cervical Plate SystemKWQ · Traditional | 05/13/2019SE |
Questions and answers
When was TRACKER Plus Kyphoplasty System cleared by the FDA?
TRACKER Plus Kyphoplasty System (K211797) received a 510(k) decision of Substantially Equivalent on October 28, 2021, 140 days after the submission was received.
What is the product code of K211797?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.