510(k) clearance
AnyPlus II Spinal Fixation System
- 510(k) number
- K261217
- Applicant
- GS Medical Co., Ltd.
- Decision date
- Oct 2, 2026
- Date received
- Apr 14, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- NKB
- Device type
- Thoracolumbosacral Pedicle Screw System
- Device class
- Class II
- Regulation
- 21 CFR 888.3070
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Cheongju-Si, KR