Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System— 510(k) K233509

Name: FDA 510(k) clearance K233509
Creator: U.S. Food and Drug Administration
Published: 2024-04-10

Substantially Equivalent

Zavation Medical Products, LLC

FDA 510(k) clearance K233509 for Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System, Substantially Equivalent on 2024-04-10. Applicant: Zavation Medical Products, LLC. Device class: 2.

Clearance details

Applicant: Zavation Medical Products, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-10-31
Decision date: 2024-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAX

view all

K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from Zavation Medical Products, LLC

view all

K253943 — Tiger 2 System2026-07-24
K243908 — Tiger 2 System2025-02-03
K231811 — Zavation Connector System2023-08-22
K223808 — Zavation Navigation Instrument System2023-07-12
K230731 — Zavation ALIF System2023-06-14

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.