BACFIX SPINAL FIXATION SYSTEM— 510(k) K964404

Substantially Equivalent for Some Indications

Spinal Concepts, Inc.

FDA 510(k) clearance K964404 for BACFIX SPINAL FIXATION SYSTEM, Substantially Equivalent for Some Indications on 1997-03-26. Applicant: Spinal Concepts, Inc..

Clearance details

Applicant: Spinal Concepts, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1996-11-04
Decision date: 1997-03-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

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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.