SPINE-TECH CERVICAL FIXATION SYSTEM— 510(k) K931653

Substantially Equivalent

Spinal Technologies

FDA 510(k) clearance K931653 for SPINE-TECH CERVICAL FIXATION SYSTEM, Substantially Equivalent on 1994-08-04. Applicant: Spinal Technologies.

Clearance details

Applicant: Spinal Technologies
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1993-04-05
Decision date: 1994-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.