RANSFORD CERVICAL FIXATION SYSTEM— 510(k) K965221

Substantially Equivalent

Surgicraft , Ltd.

FDA 510(k) clearance K965221 for RANSFORD CERVICAL FIXATION SYSTEM, Substantially Equivalent on 1997-08-07. Applicant: Surgicraft , Ltd..

Clearance details

Applicant: Surgicraft , Ltd.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1996-12-31
Decision date: 1997-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redditch, Worcestershire, GB

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.