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

Name: FDA 510(k) clearance K953416
Creator: U.S. Food and Drug Administration
Published: 1995-10-03

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.. Device class: 2.

Clearance details

Applicant: Arcan Orthopaedic Corp.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
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

Download summary PDF View on FDA.gov ↗

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More clearances from Arcan Orthopaedic Corp.

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K971457 — BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED1997-07-16
K955927 — BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)1996-03-13
K945435 — BRYAN POSTERIOR SPINAL FIXATOR (BPSF)1995-05-31
K914548 — BRYAN SPINAL FIXATER (BSF)1994-03-28

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.