BRYAN POSTERIOR SPINAL FIXATOR (BPSF)— 510(k) K953416

Substantially Equivalent for Some Indications

Arcan Orthopaedic Corp.

FDA 510(k) clearance K953416 for BRYAN POSTERIOR SPINAL FIXATOR (BPSF), Substantially Equivalent for Some Indications on 1995-10-03. Applicant: Arcan Orthopaedic Corp..

Clearance details

Applicant: Arcan Orthopaedic Corp.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1995-07-10
Decision date: 1995-10-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ogden, UT, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.