TURBO PRIME IBD SYSTEM— 510(k) K080058

Substantially Equivalent

Spineselect, LLC

FDA 510(k) clearance K080058 for TURBO PRIME IBD SYSTEM, Substantially Equivalent on 2008-04-16. Applicant: Spineselect, LLC.

Clearance details

Applicant: Spineselect, LLC
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2008-01-09
Decision date: 2008-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apple Valley, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.