Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs— 510(k) K150468

Name: FDA 510(k) clearance K150468
Creator: U.S. Food and Drug Administration
Published: 2016-02-29

Substantially Equivalent

K2 Medical GmbH & Co. KG

FDA 510(k) clearance K150468 for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs, Substantially Equivalent on 2016-02-29. Applicant: K2 Medical GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: K2 Medical GmbH & Co. KG
Product code: Code HAE
Device class: Class 2
Regulation: 21 CFR 882.4840
Advisory panel: Neurology
Date received: 2015-02-23
Decision date: 2016-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAE

view all

K242759 — Geister K-Rex rongeurs2025-06-06
K223596 — SQ.line KERRISON2023-06-29
K230256 — Rebellion, Phantom Multi-Bite Kerrison Rongeur2023-03-03
K221818 — Rebellion; Phantom Multi-Bite Kerrison Rongeur2022-10-07
K210741 — KLS Martin Neuro Rongeurs2022-06-03

More clearances from K2 Medical GmbH & Co. KG

view all

K120492 — K2 MEDICAL VASCULAR CLAMPS2012-04-30

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