FDA applicant
Shanghai Sanyou Medical Co, Ltd.
FDA records 9 decisions for Shanghai Sanyou Medical Co, Ltd. (Jiading District, CN) from 2013 to 2023: 9 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 164 days from receipt to decision, against 78 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 8 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
How often FDA has decided Shanghai Sanyou Medical Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Shanghai Sanyou Medical Co, Ltd.’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