Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K-Number: K150468 · 2016-02-29
ApplicantK2 Medical GmbH & Co. KG
Decision Date2016-02-29
Product CodeHAE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is a medical device manufactured by K2 Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2016-02-29 under approval number K150468. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is a medical device that received FDA 510(k) clearance on 2016-02-29. It is manufactured by K2 Medical GmbH & Co. KG. The 510(k) number is K150468.
When was Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs approved by the FDA?
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs received FDA 510(k) clearance on 2016-02-29, under approval number K150468.
What company makes Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is manufactured by K2 Medical GmbH & Co. KG.
What is the FDA product code for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?
The FDA product code for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is HAE.
Related Devices (Code: HAE)
K161744Symmetry Sharp Kerrison RongeurSymmetry Surgical, Inc.
K153243Fehling-PunchesFehling Instruments GmbH & Co. KG
K152734Kerrison RongeursVitalitec Medizintechnik GmbH
K180949SteribiteRjr Surgical, Inc.
K200383Wiggins Medical Surgical InstrumentsWiggins Medical
K200387Ace Medical Surgical InstrumentsAce Medical
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.