LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM— 510(k) K133525

Name: FDA 510(k) clearance K133525
Creator: U.S. Food and Drug Administration
Published: 2014-03-04

Substantially Equivalent

Changzhou Dean Medical Instrument Co, Ltd.

FDA 510(k) clearance K133525 for LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM, Substantially Equivalent on 2014-03-04. Applicant: Changzhou Dean Medical Instrument Co, Ltd.. Device class: 2.

Clearance details

Applicant: Changzhou Dean Medical Instrument Co, Ltd.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2013-11-15
Decision date: 2014-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Changzhou Dean Medical Instrument Co, Ltd.

view all

K134011 — GENERAL SPINAL SYSTEM2014-09-03

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.