HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM— 510(k) K853033

Substantially Equivalent

A.W. Showell (Surgicraft) , Ltd.

FDA 510(k) clearance K853033 for HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM, Substantially Equivalent on 1985-09-24. Applicant: A.W. Showell (Surgicraft) , Ltd..

Clearance details

Applicant: A.W. Showell (Surgicraft) , Ltd.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1985-07-18
Decision date: 1985-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Worcs. B97 6hf England, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.