510(k) Report

FDA applicant

Shanghai Reach Medical Instrument Co, Ltd.

Shanghai, CN3 decisions2021–20230 recalls

FDA records 3 decisions for Shanghai Reach Medical Instrument Co, Ltd. (Shanghai, CN) from 2021 to 2023: 3 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. 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 Shanghai Reach Medical Instrument Co, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12022: 12023: 1
2021high 1 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Shanghai Reach Medical Instrument Co, Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Reach Medical Instrument Co…’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?

  • NKBThoracolumbosacral Pedicle Screw System2decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 140 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 1 of its 3 were faster than that.

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd. · 20211cites it

What has FDA decided for it lately?

  • K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd. · 2023
  • K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd. · 2022
  • K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd. · 2021

All 3 as Shanghai Reach Medical Instrument Co, Ltd. →