Acapella Cervical Spacer System— 510(k) K171489

Substantially Equivalent

Choicespine, LP

FDA 510(k) clearance K171489 for Acapella Cervical Spacer System, Substantially Equivalent on 2017-10-23. Applicant: Choicespine, LP.

Clearance details

Applicant: Choicespine, LP
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2017-05-22
Decision date: 2017-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.