INION GTR BIODEGRADABLE MEMBRANE SYSTEM— 510(k) K033074

Name: FDA 510(k) clearance K033074
Creator: U.S. Food and Drug Administration
Published: 2004-03-31

Substantially Equivalent

Inion , Ltd.

FDA 510(k) clearance K033074 for INION GTR BIODEGRADABLE MEMBRANE SYSTEM, Substantially Equivalent on 2004-03-31. Applicant: Inion , Ltd.. Device class: 2.

Clearance details

Applicant: Inion , Ltd.
Product code: Code NPK
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2003-09-29
Decision date: 2004-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

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K060393 — INION HEXALON BIODEGRADABLE ACL/PCL SCREW2006-03-13
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Recalls naming K033074

K-number listed on FDA's recall record

Z-1478-2017 — Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.Class II·Terminated·Inion Ltd.·20170301

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033074.

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