# Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.

- Location (FDA's records): Changzhou, CN
- FDA decisions: 4 (2022–2023): 4 510(k) clearances
- Product codes: MAX (1), NKB (1), HRS (1), HSB (1)
- 510(k) review time since 2016: median 119 days, against 104 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 13 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 11 (https://510kreport.com/company/synthes-usa)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Changzhou Dingjian Medical Appliance Co., Ltd.: 1 (https://510kreport.com/company/changzhou-dingjian-medical-appliance)

## Recent decisions
- K232394: Internal Locking Plate and Screw Fixation System (Dec 15, 2023)
- K230456: SGM Femoral Nail System (Jun 30, 2023)
- K223776: PEEK Spinal Infusion Cage (Mar 3, 2023)
- K222031: Spinal Inner Fixation System (Oct 28, 2022)

Source page: https://510kreport.com/company/changzhou-geasure-medical-apparatus-and-instruments