510(k) Report

FDA applicant

Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Shanghai, CN3 decisions2014–20140 recalls

FDA records 3 decisions for Suzhou Kangli Orthopaedics Instrument Co., Ltd. (Shanghai, CN) in 2014: 3 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and HRS (Plate, Fixation, Bone). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Suzhou Kangli Orthopaedics Instrument Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2014

2014: 3
2014high 3 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Suzhou Kangli Orthopaedics Instrument Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Suzhou Kangli Orthopaedics Instrument…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation2decisions
  • HRSPlate, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K140053Kangli Pedicle Screw Spinal SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 20143cite it
  • K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 20141cites it

What has FDA decided for it lately?

  • K142290KangLi pedical screw spinal systemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
  • K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
  • K140053Kangli Pedicle Screw Spinal SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014

All 3 as Suzhou Kangli Orthopaedics Instrument Co., Ltd. →