DeviceClearance

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.. Device class: 2.

Clearance details

Applicant
Innovasis, Inc.
Product code
Code MAX
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MAX

product code MAX
Death
13
Injury
1,305
Malfunction
2,885
Total
4,203

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K180078

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180078.

Data sourced from openFDA. This site is unofficial and independent of the FDA.