TxTiHA IBF System, AxTiHA Stand-Alone ALIF System— 510(k) K201614

Name: FDA 510(k) clearance K201614
Creator: U.S. Food and Drug Administration
Published: 2020-07-15

Substantially Equivalent

Innovasis, Inc.

FDA 510(k) clearance K201614 for TxTiHA IBF System, AxTiHA Stand-Alone ALIF System, Substantially Equivalent on 2020-07-15. 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: 2020-06-15
Decision date: 2020-07-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View 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, 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 →

Recalls naming K201614

K-number listed on FDA's recall record

Z-3163-2024 — TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.Class II·Ongoing·Innovasis, Inc·20240814

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201614.

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