APOFIX CERVICAL SPINE FIXATION— 510(k) K945022

Substantially Equivalent for Some Indications

Sofamor Co.

FDA 510(k) clearance K945022 for APOFIX CERVICAL SPINE FIXATION, Substantially Equivalent for Some Indications on 1995-05-15. Applicant: Sofamor Co..

Clearance details

Applicant: Sofamor Co.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1994-10-13
Decision date: 1995-05-15
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Berck/Mer, FR

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.