BRYAN SPINAL FIXATER (BSF)— 510(k) K914548

Substantially Equivalent for Some Indications

Arcan Orthopaedic Corp.

FDA 510(k) clearance K914548 for BRYAN SPINAL FIXATER (BSF), Substantially Equivalent for Some Indications on 1994-03-28. Applicant: Arcan Orthopaedic Corp..

Clearance details

Applicant: Arcan Orthopaedic Corp.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1991-10-11
Decision date: 1994-03-28
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ogden, UT, US

Download summary PDF View on FDA.gov ↗

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.