ChanPin Pedicle Screw Spinal System— 510(k) K251251

Name: FDA 510(k) clearance K251251
Creator: U.S. Food and Drug Administration
Published: 2026-06-09

Substantially Equivalent

Chanpin Medtak Co., Ltd.

FDA 510(k) clearance K251251 for ChanPin Pedicle Screw Spinal System, Substantially Equivalent on 2026-06-09. Applicant: Chanpin Medtak Co., Ltd.. Device class: 2.

Summary

Chanpin Medtak's ChanPin Pedicle Screw Spinal System is filed under NKB, thoracolumbosacral pedicle screw systems. The record doesn't list the system's components.

Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).

Chanpin Medtak filed from New Taipei City, Taiwan. Review took 412 calendar days (April 23, 2025 to June 9, 2026).

Clearance details

Applicant: Chanpin Medtak Co., Ltd.
Product code: Product code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2025-04-23
Decision date: 2026-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKB

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K261217 — AnyPlus II Spinal Fixation System2026-10-02
K263062 — NOVIX Pedicle Screw System2026-10-01
K262712 — Duet Spinal Fixation System2026-09-30
K263172 — SAS MIS Pelvic Incidence Rods2026-09-30
K252139 — Kentrospine Viktr-MIS® Pedicle screw system2026-09-27

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.