# AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 53/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261217 |
| Device | AnyPlus II Spinal Fixation System |
| Applicant | GS Medical Co., Ltd. |
| Specialty / panel | Orthopedic |
| Product code | NKB |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-04-14 |
| Decision date | 2026-10-02 |
| Review time (days) | 171 |
| Third-party review | No |
| Applicant location | Cheongju-Si, KR |

## Why this score
- 171-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 33 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261217). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.