Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System— 510(k) K180078

Substantially Equivalent

Innovasis, Inc.

FDA 510(k) clearance K180078 for Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System, Substantially Equivalent on 2018-04-17. Applicant: Innovasis, Inc..

Clearance details

Applicant: Innovasis, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2018-01-10
Decision date: 2018-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.