AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.
AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.: 510(k) cleared for GS Medical Co., Ltd. Its amount of 171 is above the median of 138 (62nd percentile). Dated 33 days ago, it serves as a historical benchmark. Score 53/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 171 · 62th percentile of 414 FDAPulse records · 1.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 31 related KR FDAPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 62th of 414 (median 138, 1.2x median) |
| Peer records CSV (32 KR records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-02
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd. and 32 KR peers
- KR FDAPulse records like this one: 32
- AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.'s amount: 62nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
53 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 171-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 33 days ago.
What is the FDAPulse record for AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.?
AnyPlus II Spinal Fixation System (K261217) by GS Medical Co., Ltd. was cleared on 2026-10-02 after 171 days of review.
How does AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd. compare to other FDAPulse records?
Its amount of 171 sits in the upper half (62th percentile) of 414 records; the median is 138. It is 33 days old, still within a typical 45-day follow-up window.
AnyPlus II Spinal Fixation System (K261217) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| AnyPlus II Spinal Fixation System (K261217) | KR | 2026-10-02 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
Related records
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
- Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.
- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
- The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd.
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
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