FDA applicant

Solco Biomedical Company India Private Limited

Ahmedabad, IN2 decisions2021–20220 recalls

FDA records 2 decisions for Solco Biomedical Company India Private Limited (Ahmedabad, IN) from 2021 to 2022: 2 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 4 predicates, 0 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 Solco Biomedical Company India Private Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Solco Biomedical Company India Private Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Solco Biomedical Company India Private…’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

Other applicant names beginning “Solco”

FDA records each applicant name separately; these may or may not be the same firm.

Solco Biomedical Co., Ltd. 17 Solco Basle, Inc. 10 Solco Biomedical Copany India Private Limited 1

Solco Biomedical Company India Private Limited

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Solco”