BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED— 510(k) K971457

Name: FDA 510(k) clearance K971457
Creator: U.S. Food and Drug Administration
Published: 1997-07-16

Substantially Equivalent

Arcan Orthopaedic Corp.

FDA 510(k) clearance K971457 for BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED, Substantially Equivalent on 1997-07-16. Applicant: Arcan Orthopaedic Corp.. Device class: 2.

Clearance details

Applicant: Arcan Orthopaedic Corp.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 1997-03-28
Decision date: 1997-07-16
Decision: Substantially Equivalent
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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K955927 — BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)1996-03-13
K953416 — BRYAN POSTERIOR SPINAL FIXATOR (BPSF)1995-10-03
K945435 — BRYAN POSTERIOR SPINAL FIXATOR (BPSF)1995-05-31
K914548 — BRYAN SPINAL FIXATER (BSF)1994-03-28

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.